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1 INDICATIONS & USAGE Minocycline hydrochloride extended-release tablets is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.1 Indication Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline hydrochloride extended-release tablets should be used only as indicated [see Warnings and Precautions (5.11) ] .

2 DOSAGE & ADMINISTRATION The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects. The following table shows tablet strength and body weight to achieve approximately 1 mg/kg. Table 1: Dosing Table for Minocycline hydrochloride extended-release tablets Patient's Weight (lbs.) Patient's Weight (kg) Tablet Strength (mg) Actual mg/kg Dose 99 to 109 45 to 49 45 1 to 0.92 110 to 131 50 to 59 55 1.10 to 0.93 132 to 157 60 to 71 65 1.08 to 0.92 158 to 186 72 to 84 80 1.11 to 0.95 187 to 212 85 to 96 90 1.06 to 0.94 213 to 243 97 to 110 105 1.08 to 0.95 244 to 276 111 to 125 115 1.04 to 0.92 277 to 300 126 to 136 135 1.07 to 0.99 Minocycline hydrochloride extended-release tablets may be taken with or without food [see Clinical Pharmacology ( 12.3 )] . Ingestion of food along with Minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.4 )] . The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. ( 2 )

3 DOSAGE FORMS & STRENGTHS 45 mg extended release tablets: grey coloured capsule shaped film coated tablets, debossed with “45”on one side, plain on other side. 55 mg extended release tablets:Pink coloured capsule shaped film coated tablets, debossed with "55" on one side,plain on other side. 65 mg extended release tablets: blue coloured capsule shaped film coated tablets, debossed with “65”on one side, plain on other side. 80 mg extended release tablets:Greyish brown coloured capsule shaped film coated tablets, debossed with "80''on one side, plain on other side. 90 mg extended release tablets: yellow coloured capsule shaped film coated tablets, debossed with “90”on one side, plain on other side. 105 mg extended release tablets:Purple coloured capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side. 115 mg extended release tablets: green coloured capsule shaped film coated tablets, debossed with “115”on one side, plain on other side. 135 mg extended release tablets: pink (orange-brown) coloured capsule shaped film coated tablets, debossed with “135”on one side, plain on other side Extended release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg (3)

4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. (4)

5 WARNINGS AND PRECAUTIONS The use of Minocycline hydrochloride extended-release tablets during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). (5.1) If pseudomembranous colitis occurs, discontinue Minocycline hydrochloride extended-release tablets. (5.2) If liver injury is suspected, discontinue Minocycline hydrochloride extended-release tablets. (5.3) If renal impairment exists, Minocycline hydrochloride extended-release tablets doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. (5.4) Minocycline may cause central nervous system side effects including light- headedness, dizziness, or vertigo. Advise patients. (5.5) Minocycline may cause pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents. Discontinue Minocycline hydrochloride extended-release tablets if symptoms occur. (5.6) Minocycline has been associated with autoimmune syndromes; discontinue Minocycline hydrochloride extended-release tablets immediately if symptoms occur. (5.7) Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue Minocycline hydrochloride extended-release tablets immediately if symptoms occur. (5.9) 5.1 Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. Minocycline hydrochloride extended-release tablets should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child [see Nonclinical Toxicology (13.1) & Use in Specific Populations (8.1) ] . B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Use in Specific Populations (8.1) ] . 5.2 Pseudomembranous Colitis Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.

ents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.3 Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. 5.4 Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. 5.5 Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued. 5.6 Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines. If visual disturbance occurs during treatment, patients should be checked for papilledema. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. 5.7 Autoimmune Syndromes Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients.

rome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately. 5.8 Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. 5.9 Serious Skin/Hypersensitivity Reaction Cases of anaphylaxis, serious skin reactions (e.g. Stevens Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, the drug should be discontinued immediately. 5.10 Tissue Hyperpigmentation Tetracycline-class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury. 5.11 Development of Drug-Resistant Bacteria Bacterial resistance to the tetracyclines may develop in patients using Minocycline hydrochloride extended-release tablets, therefore, the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of Minocycline hydrochloride extended-release tablets, it should be used only as indicated. 5.12 Superinfection As with other antibiotic preparations, use of Minocycline hydrochloride extended-release tablets may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Minocycline hydrochloride extended-release tablets should be discontinued and appropriate therapy instituted. 5.13 Laboratory Monitoring Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

6 ADVERSE REACTIONS The most commonly observed adverse reactions (incidence ≥ 5%) are headache, fatigue, dizziness, and pruritus. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥ 1% for Minocycline hydrochloride extended-release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS (1 mg/ Kg) N=674(%) PLACEBO N=364 (%) At least one treatment-emergent event 379 (56) 197 (54) Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) Dry mouth 7 (1) 5 (1) Myalgia 7 (1) 4 (1) 6.2 Postmarketing Experience Adverse reactions that have been reported with Minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions : fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see Warnings and Precautions (5.9) ] . Autoimmune conditions : polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome. Central nervous system : pseudotumor cerebri, bulging fontanels in infants, decreased hearing. Endocrine : brown-black microscopic thyroid discoloration, abnormal thyroid function. Oncology : thyroid cancer. Oral : glossitis, dysphagia, tooth discoloration. Gastrointestinal : enterocolitis, pancreatitis, hepatitis, liver failure. Renal : reversible acute renal failure. Hematology : hemolytic anemia, thrombocytopenia, eosinophilia. Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicology (13.1) ] .

<table cellspacing="0" cellpadding="0" border="0" width="718.2"><caption>Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects </caption><colgroup><col width="40%"/><col width="35.5555555555556%"/><col width="24.4444444444444%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"><content styleCode="bold">Adverse Reactions</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">MINOCYCLINE</content> <content styleCode="bold">HYDROCHLORIDE</content> <content styleCode="bold">EXTENDED-RELEASE</content> <content styleCode="bold">TABLETS</content> <content styleCode="bold">(1 mg/ Kg)</content> <content styleCode="bold">N=674(%)</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">PLACEBO</content> <content styleCode="bold">N=364 (%)</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">At least one treatment-emergent event </td><td styleCode="Rrule" align="center" valign="top">379 (56) </td><td styleCode="Rrule" align="center" valign="top">197 (54) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Headache </td><td styleCode="Rrule" align="center" valign="top">152 (23) </td><td styleCode="Rrule" align="center" valign="top">83 (23) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Fatigue </td><td styleCode="Rrule" align="center" valign="top">62 (9) </td><td styleCode="Rrule" align="center" valign="top">24 (7) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Dizziness </td><td styleCode="Rrule" align="center" valign="top">59 (9) </td><td styleCode="Rrule" align="center" valign="top">17 (5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Pruritus </td><td styleCode="Rrule" align="center" valign="top">31 (5) </td><td styleCode="Rrule" align="center" valign="top">16 (4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Malaise </td><td styleCode="Rrule" align="center" valign="top">26 (4) </td><td styleCode="Rrule" align="center" valign="top">9 (3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Mood alteration </td><td styleCode="Rrule" align="center" valign="top">17 (3) </td><td styleCode="Rrule" align="center" valign="top">9 (3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Somnolence </td><td styleCode="Rrule" align="center" valign="top">13 (2) </td><td styleCode="Rrule" align="center" valign="top">3 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Urticaria </td><td styleCode="Rrule" align="center" valign="top">10 (2) </td><td styleCode="Rrule" align="center" valign="top">1 (0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Tinnitus </td><td styleCode="Rrule" align="center" valign="top">10 (2) </td><td styleCode="Rrule" align="center" valign="top">5 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Arthralgia </td><td styleCode="Rrule" align="center" valign="top">9 (1) </td><td styleCode="Rrule" align="center" valign="top">2 (0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Vertigo </td><td styleCode="Rrule" align="center" valign="top">8 (1) </td><td styleCode="Rrule" align="center" valign="top">3 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="t

e="Rrule" align="center" valign="top">2 (0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Vertigo </td><td styleCode="Rrule" align="center" valign="top">8 (1) </td><td styleCode="Rrule" align="center" valign="top">3 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="t op">Dry mouth </td><td styleCode="Rrule" align="center" valign="top">7 (1) </td><td styleCode="Rrule" align="center" valign="top">5 (1) </td></tr><tr><td styleCode="Lrule Rrule" valign="top">Myalgia </td><td styleCode="Rrule" align="center" valign="top">7 (1) </td><td styleCode="Rrule" align="center" valign="top">4 (1) </td></tr></tbody></table>

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. (7.1) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. (7.3) To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. (7.5) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 7.3 Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 7.4 Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations. 7.5 Low Dose Oral Contraceptives In a multi-center study to evaluate the effect of Minocycline hydrochloride extended-release tablets on low dose oral contraceptives, hormone levels over one menstrual cycle with and without Minocycline hydrochloride extended-release tablets 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, cannot be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. 7.6 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

8 USE IN SPECIFIC POPULATION • Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. ( 5.1 , 8.1 ) •The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. ( 5.1 , 8.4 ) 8.1 Pregnancy Teratogenic Effects: Pregnancy category D [see Warnings and Precautions (5.1) ] Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use Minocycline hydrochloride extended-release tablets). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals). 8.3 Nursing Mothers Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see Warnings and Precautions (5.1) ] . 8.4 Pediatric Use Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older.

discontinue the drug, taking into account the importance of the drug to the mother [see Warnings and Precautions (5.1) ] . 8.4 Pediatric Use Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions (5.1) ]. 8.5 Geriatric Use Clinical studies of Minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

8.1 Pregnancy Teratogenic Effects: Pregnancy category D [see Warnings and Precautions (5.1) ] Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use Minocycline hydrochloride extended-release tablets). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

8.3 Nursing Mothers Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see Warnings and Precautions (5.1) ] .

8.4 Pediatric Use Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions (5.1) ].

8.5 Geriatric Use Clinical studies of Minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S -(4α,4aα,5aα, 12aα)] - 4,7 – Bis (dimethylamino) -1,4,4a,5,5a,6,11,12a - octahydro-3,10,12,12a -tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below: C23H27N3O7•HCl M. W. 493.95 Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of Minocycline hydrochloride extended-release tablets for the treatment of acne is unknown. 12.2 Pharmacodynamics The pharmacodynamics of Minocycline hydrochloride extended-release tablets for the treatment of acne is unknown. 12.3 Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, Minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC(0-24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both product. A single-dose, four-way crossover study demonstrated that Minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, Minocycline hydrochloride extended-release tablets 55mg,80 mg, and 105 mg were shown to be dose-proportional to Minocycline hydrochloride extended-release tablets 90 mg and 135 mg. When Minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum.

12.3 Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, Minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC(0-24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both product. A single-dose, four-way crossover study demonstrated that Minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, Minocycline hydrochloride extended-release tablets 55mg,80 mg, and 105 mg were shown to be dose-proportional to Minocycline hydrochloride extended-release tablets 90 mg and 135 mg. When Minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis — In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both genders with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females. Mutagenesis —Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility —Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. Minocycline hydrochloride extended-release tablets should not be used by individuals of either gender who are attempting to conceive a child.

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis — In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both genders with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females. Mutagenesis —Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility —Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Minocycline hydrochloride extended-release tablets) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. Minocycline hydrochloride extended-release tablets should not be used by individuals of either gender who are attempting to conceive a child.

14 CLINICAL STUDIES The safety and efficacy of Minocycline hydrochloride extended-release tablets in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, trials in subjects ≥ 12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%). In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received Minocycline hydrochloride extended-release tablets or placebo for a total of 12 weeks, according to the following dose assignments. Table 3: Clinical Studies Dosing Table Subject's Weight (lbs.) Subject's Weight (kg) Available Tablet Strength (mg) Actual mg/kg Dose 99 to 131 45 to 59 45 1 to 0.76 132 to 199 60 to 90 90 1.5 to 1 200 to 300 91 to 136 135 1.48 to 0.99 The two primary efficacy endpoints were: Mean percent change in inflammatory lesion counts from Baseline to 12 weeks. Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks. Efficacy results are presented in Table 4. Table 4: Efficacy Results at Week 12 *Evaluator's Global Severity Assessment Trail 1 Trail 2 Minocycline hydrochloride extended-release tablets (1mg/Kg) N=300 Placebo N=151 Minocycline hydrochloride extended-release tablets (1mg/Kg) N=315 Placebo N=158 Mean Percent Improvement in Inflammatory Lesions 43.1% 31.7% 45.8% 30.8% No. (%) of Subjects Clear or Almost Clear on the EGSA* 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%) Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

<table cellspacing="0" cellpadding="0" border="0" width="624"><caption>Table 3: Clinical Studies Dosing Table </caption><colgroup><col width="21.1538461538462%"/><col width="24.0384615384615%"/><col width="32.6923076923077%"/><col width="22.1153846153846%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top"><content styleCode="bold">Subject&apos;s Weight (lbs.)</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Subject&apos;s Weight (kg)</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Available Tablet Strength (mg)</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Actual mg/kg Dose</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top">99 to 131 </td><td styleCode="Rrule" align="center" valign="top">45 to 59 </td><td styleCode="Rrule" align="center" valign="top">45 </td><td styleCode="Rrule" align="center" valign="top">1 to 0.76 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top">132 to 199 </td><td styleCode="Rrule" align="center" valign="top">60 to 90 </td><td styleCode="Rrule" align="center" valign="top">90 </td><td styleCode="Rrule" align="center" valign="top">1.5 to 1 </td></tr><tr><td styleCode="Lrule Rrule" align="center" valign="top">200 to 300 </td><td styleCode="Rrule" align="center" valign="top">91 to 136 </td><td styleCode="Rrule" align="center" valign="top">135 </td><td styleCode="Rrule" align="center" valign="top">1.48 to 0.99 </td></tr></tbody></table>

align="top">1.5 to 1 </td></tr><tr><td styleCode="Lrule Rrule" align="center" valign="top">200 to 300 </td><td styleCode="Rrule" align="center" valign="top">91 to 136 </td><td styleCode="Rrule" align="center" valign="top">135 </td><td styleCode="Rrule" align="center" valign="top">1.48 to 0.99 </td></tr></tbody></table> <table cellspacing="0" cellpadding="0" border="0" width="635"><caption>Table 4: Efficacy Results at Week 12 </caption><colgroup><col width="28.1889763779528%"/><col width="17.007874015748%"/><col width="17.007874015748%"/><col width="18.8976377952756%"/><col width="18.8976377952756%"/></colgroup><tfoot><tr><td colspan="3"> *Evaluator&apos;s Global Severity Assessment </td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" rowspan="2" valign="top"> </td><td styleCode="Rrule" colspan="2" align="center" valign="top"><content styleCode="bold">Trail 1</content> </td><td styleCode="Rrule" colspan="2" align="center" valign="top"><content styleCode="bold">Trail 2</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top"><content styleCode="bold">Minocycline hydrochloride extended-release tablets</content> <content styleCode="bold">(1mg/Kg)</content> <content styleCode="bold">N=300</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Placebo</content> <content styleCode="bold">N=151</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Minocycline hydrochloride extended-release tablets</content> <content styleCode="bold">(1mg/Kg)</content> <content styleCode="bold">N=315</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Placebo</content> <content styleCode="bold">N=158</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">Mean Percent Improvement in Inflammatory Lesions </td><td styleCode="Rrule" align="center" valign="middle">43.1% </td><td styleCode="Rrule" align="center" valign="middle">31.7% </td><td styleCode="Rrule" align="center" valign="middle">45.8% </td><td styleCode="Rrule" align="center" valign="middle">30.8% </td></tr><tr><td styleCode="Lrule Rrule" align="center" valign="middle">No. (%) of Subjects Clear or Almost Clear on the EGSA* </td><td styleCode="Rrule" align="center" valign="middle">52 (17.3%) </td><td styleCode="Rrule" align="center" valign="middle">12 (7.9%) </td><td styleCode="Rrule" align="center" valign="middle">50 (15.9%) </td><td styleCode="Rrule" align="center" valign="middle">15 (9.5%) </td></tr></tbody></table>

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride equivalent to 105 mg minocycline, are supplied as follows. The 105 mg extended release tablets are Purple colored capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.Each tablet contains Minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 63629-9208-1 Bottles of 30 Storage Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION [See FDA-approved patient labeling (Patient Information)] Patients taking Minocycline hydrochloride extended-release tablets should receive the following information and instructions: Minocycline hydrochloride extended-release tablets should not be used by pregnant women or women attempting to conceive a child [see Use in Specific Populations (8.1) , Nonclinical Toxicology (13.1) ]. It is recommended that Minocycline hydrochloride extended-release tablets not be used by men who are attempting to father a child [see Nonclinical Toxicology (13.1) ]. Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention. Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness. Patients who experience central nervous system symptoms [see Warnings and Precautions (5.5) ] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision. Concurrent use of tetracycline may render oral contraceptives less effective [see Drug Interactions (7.5) ]. Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help. Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema. Minocycline hydrochloride extended-release tablets should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future. Patients should be advised to swallow Minocycline hydrochloride extended-release tablets whole and not to chew, crush, or split the tablets. Manufactured by: Alkem Laboratories Limited, Mumbai - 400 013, INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Patient Information Minocycline hydrochloride extended-release tablets Rx only Read this Patient information Leaflet that comes with Minocycline hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. What is Minocycline hydrochloride extended-release tablets?

flet that comes with Minocycline hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. What is Minocycline hydrochloride extended-release tablets? Minocycline hydrochloride extended-release tablets is a tetracycline-class drug. Minocycline hydrochloride extended-release tablets is prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older. Minocycline hydrochloride extended-release tablets is not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known if Minocycline hydrochloride extended-release tablets is: safe for use longer than 12 weeks. safe and effective for the treatment of infections. safe and effective in children under the age of 12 years. Who should not take Minocycline hydrochloride extended-release tablets? Do not take Minocycline hydrochloride extended-release tablets if you are allergic to tetracycline-class drugs. Ask your doctor or pharmacist for a list of these medicines if you are not sure. What should I tell my doctor before taking Minocycline hydrochloride extended-release tablets? Before you take Minocycline hydrochloride extended-release tablets tell your doctor if you: have kidney problems. Your doctor may prescribe a lower dose of medicine for you. have liver problems. have diarrhea or watery stools. have vision problems. plan to have surgery with general anesthesia. have any other medical conditions. are a male, and you and your female partner are trying to conceive a baby. You should not take Minocycline hydrochloride extended-release tablets. are pregnant or plan to become pregnant. Minocycline hydrochloride extended- release tablets may harm your unborn baby. Taking Minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking Minocycline hydrochloride extended- release tablets if you plan to become pregnant, or if you are already taking Minocycline hydrochloride extended-release tablets and plan to become pregnant. Stop taking Minocycline hydrochloride extended-release tablets and call your doctor right away if you become pregnant while taking Minocycline hydrochloride extended-release tablets. are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your milk and may harm your baby. You and your doctor should decide if you will take Minocycline hydrochloride extended-release tablets or breastfeed. You should not do both. Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements . Minocycline hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how Minocycline hydrochloride extended-release tablets works. Especially tell your doctor if you take: birth control pills . Minocycline hydrochloride extended-release tablets may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking Minocycline hydrochloride extended-release tablets. a blood thinner medicine. a penicillin antibiotic medicine . Minocycline hydrochloride extended-release tablets and penicillins should not be used together. antacids that contain aluminum, calcium, or magnesium or iron-containing products . an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline hydrochloride extended-release tablets and isotretinoin should not be used together.

ded-release tablets and penicillins should not be used together. antacids that contain aluminum, calcium, or magnesium or iron-containing products . an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline hydrochloride extended-release tablets and isotretinoin should not be used together. Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. How should I take Minocycline hydrochloride extended-release tablets? Take Minocycline hydrochloride extended-release tablets exactly as your doctor tells you. Skipping doses or not taking all doses of Minocycline hydrochloride extended-release tablets may: make the treatment not work as well. increase the chance that the bacteria will become resistant to Minocycline hydrochloride extended-release tablets. Minocycline hydrochloride extended-release tablets can be taken with or without food . Taking Minocycline hydrochloride extended-release tablets with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. Swallow Minocycline hydrochloride extended-release tablets whole. Do not chew, crush, or split the tablets. If you take too much Minocycline hydrochloride extended-release tablets, call your doctor or poison control center right away . Your doctor may do blood tests to check you for side effects during treatment with Minocycline hydrochloride extended-release tablets. What should I avoid while taking Minocycline hydrochloride extended-release tablets? Avoid sunlight, sunlamps, and tanning beds. Minocycline hydrochloride extended-release tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn. Protect your skin while out in sunlight. You should not drive or operate dangerous machinery until you know how Minocycline hydrochloride extended-release tablets affects you. Minocycline hydrochloride extended-release tablets may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo). What are possible side effects of Minocycline hydrochloride extended-release tablets? Minocycline hydrochloride extended-release tablets may cause serious side effects, including: Harm to an unborn baby . See "What should I tell my doctor before taking Minocycline hydrochloride extended-release tablets?" Permanent teeth discoloration . Minocycline hydrochloride extended-release tablets may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Minocycline hydrochloride extended-release tablets should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See "What should I tell my doctor before taking Minocycline hydrochloride extended-release tablets?" Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including Minocycline hydrochloride extended-release tablets. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. Serious liver problems . Stop taking Minocycline hydrochloride extended-release tablets and call your doctor right away if you get any of the following symptoms of liver problems: loss of appetite tiredness diarrhea yellowing of your skin or the whites of your eyes unexplained bleeding confusion sleepiness Central nervous system effects .

ms . Stop taking Minocycline hydrochloride extended-release tablets and call your doctor right away if you get any of the following symptoms of liver problems: loss of appetite tiredness diarrhea yellowing of your skin or the whites of your eyes unexplained bleeding confusion sleepiness Central nervous system effects . See "What should I avoid while taking Minocycline hydrochloride extended-release tablets?" Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with Minocycline hydrochloride extended-release tablets or if treatment is stopped. Benign intracranial hypertension, also called pseudotumor cerebri . This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking Minocycline hydrochloride extended-release tablets and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches. Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis ). Using Minocycline hydrochloride extended-release tablets for a long time to treat acne may cause immune system reactions. Tell your doctor right away if you get a fever, rash, joint pain, or body weakness. Your doctor may do tests to check your blood for immune system reactions. Serious rash and allergic reactions . Minocycline hydrochloride extended-release tablets may cause a serious rash and allergic reactions that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death. Stop taking Minocycline hydrochloride extended-release tablets and get medical help right away if you have any of these symptoms: skin rash, hives, sores in your mouth, or your skin blisters and peels swelling of your face, eyes, lips, tongue, or throat trouble swallowing or breathing blood in your urine fever, yellowing of the skin or the whites of your eyes, dark colored urine pain on the right side of the stomach area (abdominal pain) chest pain or abnormal heartbeats swelling in your legs, ankles, and feet darkening of your nails, skin, eyes, scars, teeth, and gums The most common side effects of Minocycline hydrochloride extended-release tablets include: headache tiredness dizziness or spinning feeling itching Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with Minocycline hydrochloride extended-release tablets. These are not all the side effects with Minocycline hydrochloride extended-release tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store minocycline hydrochloride extended-release tablets? Store minocycline hydrochloride extended-release tablets between 68°F to 77°F (20°C to 25°C). Keep Minocycline hydrochloride extended-release tablets in the container that it comes in and keep the container tightly closed. Keep Minocycline hydrochloride extended-release tablets dry. Keep Minocycline hydrochloride extended-release tablets and all medicines out of the reach of children. General information about Minocycline hydrochloride extended-release tablets Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Minocycline hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.

poses other than those listed in the Patient Information leaflet. Do not use Minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Minocycline hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about Minocycline hydrochloride extended-release tablets. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about Minocycline hydrochloride extended-release tablets that is written for health professionals. For more information, call 1-877-ASC-RX01 (877-272-7901). What are the ingredients in Minocycline hydrochloride extended-release tablets? Active ingredient: minocycline HCl. Inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Alkem Laboratories Limited, Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: September,2019 PT 3278-01

1 INDICATIONS & USAGE Minocycline hydrochloride extended-release tablets is indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )]. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions ( 5.12 )]. Minocycline hydrochloride extended-release tablets is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated. ( 1 )

2 DOSAGE & ADMINISTRATION The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Table 1 provides the recommended minocycline hydrochloride extended-release tablets dosage based upon weight ranges. Table 1: Dosing Table for Minocycline hydrochloride extended-release tablets Patient's Weight(kg) Recommended Dosage (mg/day) 45 to 49 45 50 to 59 55 60 to 71 65 72 to 84 80 85 to 96 90 97 to 110 105 111 to 125 115 126 to 136 135 Higher dosages have not shown to be of additional benefit in the treatment of inflammatory lesions of acne and may be associated with more acute vestibular adverse reactions. Swallow tablets whole. Do not chew, crush, or split the extended-release tablets. Administer minocycline hydrochloride extended-release tablets with or without food [see Clinical Pharmacology ( 12.3 )]. Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, decrease the daily dosage by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions ( 5.9 )]. The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. ( 2 )

3 DOSAGE FORMS & STRENGTHS 45 mg extended-release tablets: grey coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. 55 mg extended-release tablets: Pink coloured capsule shaped film coated tablets, debossed with "55" on one side, plain on other side. 65 mg extended-release tablets: blue coloured capsule shaped film coated tablets, debossed with “65” on one side, plain on other side. 80 mg extended-release tablets: Greyish brown coloured capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side. 90 mg extended-release tablets: yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side. 105 mg extended-release tablets: Purple coloured capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side. 115 mg extended-release tablets: green coloured capsule shaped film coated tablets, debossed with “115” on one side, plain on other side. 135 mg extended-release tablets: pink (orange-brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side Extended-release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg ( 3 )

4 CONTRAINDICATIONS Minocycline hydrochloride extended-release tablets is contraindicated in patients with history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to any of the tetracyclines. ( 4 )

5 WARNINGS AND PRECAUTIONS Serious Skin/Hypersensitivity Reactions: Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.2 , 8.1 , 8.4 ) Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.3 , 8.1 , 8.4 ) Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis): Discontinue if Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) occurs. ( 5.4 ) Hepatotoxicity: Discontinue if liver injury is suspected. ( 5.5 ) Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo. ( 5.6 ) Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue if symptoms occur. ( 5.7 ) Autoimmune Syndromes: Minocycline has been associated with autoimmune syndromes; discontinue immediately if symptoms occur. ( 5.8 ) Metabolic Effects: If renal impairment exists, reduce minocycline hydrochloride extended-release tablets dosage. ( 5.9 ) 5.1 Serious Skin/Hypersensitivity Reactions Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, minocycline hydrochloride extended-release tablets should be discontinued immediately. Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines [see ADVERSE REACTIONS ( 6.2 )] . If severe skin/hypersensitivity reactions occur, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy. 5.2 Tooth Discoloration and Enamel Hypoplasia The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-graybrown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of minocycline hydrochloride extended-release tablets is not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets is used during the second or third trimester of pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )].

d. Use of minocycline hydrochloride extended-release tablets is not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets is used during the second or third trimester of pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )]. 5.3 Inhibition of Bone Growth The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including minocycline hydrochloride extended-release tablets, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets is used during the second or third trimester of pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )]. 5.4 Clostridioides difficile Associated Diarrhea (Antibiotic Associated Colitis) Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, discontinue minocycline hydrochloride extended-release tablets. 5.5 Hepatotoxicity Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal), have been reported with minocycline use in the treatment of acne. Discontinue minocycline hydrochloride extended-release tablets if liver injury is suspected. 5.6 Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on minocycline hydrochloride extended-release tablets. These symptoms may disappear during therapy and usually rapidly disappear when minocycline hydrochloride extended-release tablets is discontinued. 5.7 Idiopathic Intracranial Hypertension Idiopathic intracranial hypertension has been associated with the use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and minocycline hydrochloride extended-release tablets because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension. Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted.

cycline hydrochloride extended-release tablets because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension. Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize. 5.8 Autoimmune Syndromes Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis, and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Evaluate symptomatic patients. If symptoms occur, immediately discontinue use of minocycline hydrochloride extended-release tablets. 5.9 Metabolic Effects The anti-anabolic action of the tetracyclines, including minocycline hydrochloride extended-release tablets, may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, lower the total doses of minocycline hydrochloride extended-release tablets, and if therapy is prolonged, monitor serum levels minocycline hydrochloride extended-release tablets. 5.10 Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (e.g., tanning beds or UVA/B treatment) while using minocycline hydrochloride extended-release tablets. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided. 5.11 Tissue Hyperpigmentation Tetracycline-class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (e.g., teeth, mucosa, alveolar bone), sclerae, and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury. 5.12 Development of Drug-Resistant Bacteria Bacterial resistance to tetracyclines may develop in patients using minocycline hydrochloride extended-release tablets. Because of the potential for drug-resistant bacteria to develop during the use of minocycline hydrochloride extended-release tablets, it should be used only as indicated. 5.13 Superinfection Use of minocycline hydrochloride extended-release tablets may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy. 5.14 Laboratory Monitoring Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Central Nervous System Effects [see Warnings and Precautions ( 5.6 )] Idiopathic Intracranial Hypertension [see Warnings and Precautions ( 5.7 )] The most commonly observed adverse reactions (incidence ≥ 5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets and higher than placebo. Table 2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical Trial Subjects and Higher than Placebo Adverse Reactions Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 674 (%) PLACEBO N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) 6.2 Postmarketing Experience The following adverse reactions have been reported with minocycline hydrochloride use in a variety of indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens- Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome. Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function. Oncology: thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

<table cellspacing="0" cellpadding="0" border="0" width="718.2"><colgroup><col width="40%"/><col width="35.5555555555556%"/><col width="24.4444444444444%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"><content styleCode="bold">Adverse Reactions</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Minocycline Hydrochloride Extended-Release Tablets</content> <content styleCode="bold">(1 mg/kg)</content> <content styleCode="bold">N = 674 (%)</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">PLACEBO</content> <content styleCode="bold"/> <content styleCode="bold"/> <content styleCode="bold">N = 364 (%)</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">At least one treatment-emergent event </td><td styleCode="Rrule" align="center" valign="top">379 (56) </td><td styleCode="Rrule" align="center" valign="top">197 (54) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Fatigue </td><td styleCode="Rrule" align="center" valign="top">62 (9) </td><td styleCode="Rrule" align="center" valign="top">24 (7) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Dizziness </td><td styleCode="Rrule" align="center" valign="top">59 (9) </td><td styleCode="Rrule" align="center" valign="top">17 (5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Pruritus </td><td styleCode="Rrule" align="center" valign="top">31 (5) </td><td styleCode="Rrule" align="center" valign="top">16 (4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Malaise </td><td styleCode="Rrule" align="center" valign="top">26 (4) </td><td styleCode="Rrule" align="center" valign="top">9 (3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Somnolence </td><td styleCode="Rrule" align="center" valign="top">13 (2) </td><td styleCode="Rrule" align="center" valign="top">3 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Urticaria </td><td styleCode="Rrule" align="center" valign="top">10 (2) </td><td styleCode="Rrule" align="center" valign="top">1 (0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Tinnitus </td><td styleCode="Rrule" align="center" valign="top">10 (2) </td><td styleCode="Rrule" align="center" valign="top">5 (1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Arthralgia </td><td styleCode="Rrule" align="center" valign="top">9 (1) </td><td styleCode="Rrule" align="center" valign="top">2 (0) </td></tr><tr><td styleCode="Lrule Rrule" valign="top">Vertigo </td><td styleCode="Rrule" align="center" valign="top">8 (1) </td><td styleCode="Rrule" align="center" valign="top">3 (1) </td></tr></tbody></table>

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving minocycline hydrochloride extended-release tablets in conjunction with penicillin. 7.3 Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations. 7.4 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 ) 8.1 Pregnancy Risk Summary Tetracycline class drugs, including minocycline hydrochloride extended-release tablets may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.4 )]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage. In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions ( 5.2 )] . Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions ( 5.3 )]. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline. 8.2 Lactation Risk Summary Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during minocycline hydrochloride extended-release tablets therapy and for 4 days after the final dose [see Warnings and Precautions ( 5.2 , 5.3 )] . 8.4 Pediatric Use The safety and effectiveness of minocycline hydrochloride extended-release tablets have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Clinical Studies ( 14 )] . Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution ( 5.2 , 5.3 )] . Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions ( 5.2 )] . Safety and effectiveness of minocycline hydrochloride extended-release tablets have not been established in pediatric patients younger than 12 years of age. 8.5 Geriatric Use Clinical studies of minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

8.1 Pregnancy Risk Summary Tetracycline class drugs, including minocycline hydrochloride extended-release tablets may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.4 )]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage. In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions ( 5.2 )] . Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions ( 5.3 )]. Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

8.2 Lactation Risk Summary Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during minocycline hydrochloride extended-release tablets therapy and for 4 days after the final dose [see Warnings and Precautions ( 5.2 , 5.3 )] .

8.4 Pediatric Use The safety and effectiveness of minocycline hydrochloride extended-release tablets have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Clinical Studies ( 14 )] . Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution ( 5.2 , 5.3 )] . Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions ( 5.2 )] . Safety and effectiveness of minocycline hydrochloride extended-release tablets have not been established in pediatric patients younger than 12 years of age.

8.5 Geriatric Use Clinical studies of minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

10 OVERDOSAGE Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline hydrochloride extended-release tablets, treat symptomatically, and institute supportive measures. Call Poison Control Center at 1-800-222-1222 for the latest recommendations.

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S -(4α,4aα,5aα, 12aα)]-4,7–Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HCl M. W. 493.95 Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown. 12.2 Pharmacodynamics The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown. 12.3 Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended-release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively. These parameters are based on dose adjusted to 135 mg/day for both products. A single-dose, four-way crossover study demonstrated that minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, minocycline hydrochloride extended-release tablets 55 mg, 80 mg, and 105 mg were shown to be doseproportional to minocycline hydrochloride extended-release tablets 90 mg and 135 mg. When minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum.

12.3 Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended-release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively. These parameters are based on dose adjusted to 135 mg/day for both products. A single-dose, four-way crossover study demonstrated that minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, minocycline hydrochloride extended-release tablets 55 mg, 80 mg, and 105 mg were shown to be doseproportional to minocycline hydrochloride extended-release tablets 90 mg and 135 mg. When minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females. Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (40 times the MRHD on an AUC comparison basis). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (15 to 40 times the MRHD on an AUC comparison basis) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females. Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (40 times the MRHD on an AUC comparison basis). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (15 to 40 times the MRHD on an AUC comparison basis) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

14 CLINICAL STUDIES The safety and efficacy of minocycline hydrochloride extended-release tablets in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled trials in adult and pediatric subjects 12 years of age and older (Trial 1 and Trial 2). A total of 924 subjects with non-nodular moderate to severe acne vulgaris received minocycline hydrochloride extended-release tablets or placebo for a total of 12 weeks. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%). The two primary efficacy endpoints were: 1) Mean percent change in inflammatory lesion counts from Baseline to 12 weeks. 2) Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks. Efficacy results are presented in Table 4. Table 4: Efficacy Results at Week 12 in Subjects with Non-nodular Moderate to Severe Acne Vulgaris in Trial 1 and Trial 2 Trial 1 Trial 2 Minocycline hydrochloride extended-release tablets (1 mg/kg) N = 300 Placebo N = 151 Minocycline hydrochloride extended-release tablets (1 mg/kg) N = 315 Placebo N = 158 Mean Percent Improvement in Inflammatory Lesions 43.1% 31.7% 45.8% 30.8% No. (%) of Subjects Clear or Almost Clear on the EGSA* 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%) * Evaluator's Global Severity Assessment Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

<table cellspacing="0" cellpadding="0" border="0" width="613"><colgroup><col width="25.4624591947769%"/><col width="25.4624591947769%"/><col width="13.7105549510337%"/><col width="0.108813928182807%"/><col width="23.3949945593036%"/><col width="11.7519042437432%"/><col width="0.108813928182807%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" rowspan="2" align="center" valign="top"> </td><td styleCode="Rrule" colspan="3" align="center" valign="top"><content styleCode="bold">Trial 1</content> </td><td styleCode="Rrule" colspan="3" align="center" valign="top"><content styleCode="bold">Trial 2</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="top"><content styleCode="bold">Minocycline hydrochloride extended-release tablets</content> <content styleCode="bold">(1 mg/kg)</content> <content styleCode="bold">N = 300</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Placebo</content> <content styleCode="bold">N = 151</content> </td><td styleCode="Rrule" colspan="2" align="center" valign="top"><content styleCode="bold">Minocycline hydrochloride extended-release tablets</content> <content styleCode="bold">(1 mg/kg)</content> <content styleCode="bold">N = 315</content> </td><td styleCode="Rrule" align="center" valign="top"><content styleCode="bold">Placebo</content> <content styleCode="bold">N = 158</content> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Mean Percent Improvement in Inflammatory Lesions </td><td styleCode="Rrule" align="center" valign="middle">43.1% </td><td styleCode="Rrule" align="center" valign="middle">31.7% </td><td styleCode="Rrule" colspan="2" align="center" valign="middle">45.8% </td><td styleCode="Rrule" align="center" valign="middle">30.8% </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">No. (%) of Subjects Clear or Almost Clear on the EGSA* </td><td styleCode="Rrule" align="center" valign="middle">52 (17.3%) </td><td styleCode="Rrule" align="center" valign="middle">12 (7.9%) </td><td styleCode="Rrule" colspan="2" align="center" valign="middle">50 (15.9%) </td><td styleCode="Rrule" align="center" valign="middle">15 (9.5%) </td><td styleCode="Rrule" valign="middle"> </td></tr></tbody></table>

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride. The 55 mg extended release tablets are Pink colored capsule shaped film coated tablets, debossed with "55" on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 72162-1838-3: 30 Tablets in a Bottle 16.2 Storage Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. 16.3 Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking minocycline hydrochloride extended-release tablets should receive the following information and instructions: Administration Instructions Minocycline hydrochloride extended-release tablets should be taken exactly as directed. Advise patients to swallow minocycline hydrochloride extended-release tablets whole and not to chew, crush, or split the tablets [see Dosage and Administration ( 2 )] . Serious Skin/Hypersensitivity Reactions Inform patients that serious skin reactions have occurred with the minocycline use in patients with acne. Advise patients to discontinue use of minocycline hydrochloride extended-release tablets and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions ( 5.1 )] . Tooth Discoloration and Enamel Hypoplasia Advise patients that minocycline hydrochloride extended-release tablets use in pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise patients to discontinue minocycline hydrochloride extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )] . Advise caregivers of pediatric patients that minocycline hydrochloride extended-release tablets use may cause permanent discoloration of deciduous and permanent teeth [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.4 )] . Inhibition of Bone Growth Advise patients that minocycline hydrochloride extended-release tablets use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue minocycline hydrochloride extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 )]. Clostridioides difficile- Associated Diarrhea (Antibiotic-Associated Colitis) Advise patients that Clostridioides difficile- associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including SOLODYN. If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions ( 5.4 )] . Hepatotoxicity Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness [see Warnings and Precautions ( 5.5 )] . Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on minocycline hydrochloride extended-release tablets [see Warnings and Precautions ( 5.6 )] . Idiopathic Intracranial Hypertension Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions ( 5.7 )] .

)] . Idiopathic Intracranial Hypertension Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions ( 5.7 )] . Autoimmune Syndromes Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise. Advise patients who experience such symptoms to immediately discontinue minocycline hydrochloride extended-release tablets and seek medical help [see Warnings and Precautions ( 5.8 )] . Photosensitivity Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (i.e., tanning beds or UVA/B treatment) while using minocycline hydrochloride extended-release tablets. Instruct patients to use sunscreen and wear protective clothing (e.g., hat) over treated areas when exposure to sun cannot be avoided [see Warnings and Precautions ( 5.10 )] . Tissue Hyperpigmentation Inform patients that minocycline hydrochloride extended-release tablets may cause discoloration of skin, scars, teeth, or gums [see Warnings and Precautions ( 5.11 )] . Lactation Advise patients that minocycline hydrochloride extended-release tablets therapy is not recommended during breast feeding for 4 days after the final dose [see Use in Specific Populations ( 8.2 )] . Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921

PATIENT INFORMATION Minocycline hydrochloride (min-oh-sye-kleen hye-droe-KLOR-ide) extended-release tablets What is m inocycline hydrochloride extended-release tablets ? Minocycline hydrochloride extended-release tablets is a prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years of age and older. Minocycline hydrochloride extended-release tablets is not effective for acne that is not red-looking (non-inflammatory acne). It is not known if minocycline hydrochloride extended-release tablets is: safe and effective for the treatment of infections. safe and effective in children under 12 years of age. Who should not take minocycline hydrochloride extended-release tablets ? Do not take minocycline hydrochloride extended-release tablets if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Before taking minocycline hydrochloride extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have liver problems have diarrhea or watery stools have had increased pressure around your brain that may have caused vision problems are pregnant or plan to become pregnant. Minocycline hydrochloride extended-release tablets may harm your unborn baby. Taking minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away if you become pregnant during treatment with minocycline hydrochloride extended-release tablets. are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your breast milk and may harm your baby. Do not breastfeed during treatment with minocycline hydrochloride extended-release tablets and for 4 days after your final dose. Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Minocycline hydrochloride extended-release tablets and other medicines may affect each other and can cause serious side effects. Minocycline hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how minocycline hydrochloride extended-release tablets works. Especially tell your healthcare provider if you take: a blood thinner medicine a penicillin antibiotic medicine antacids that contain aluminum, calcium, or magnesium or iron-containing medicines an acne medicine that contains isotretinoin Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist. How should I take minocycline hydrochloride extended-release tablets ? Take minocycline hydrochloride extended-release tablets exactly as your healthcare provider tells you. Take minocycline hydrochloride extended-release tablets 1 time per day with or without food. Taking minocycline hydrochloride extended-release tablets with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. Swallow minocycline hydrochloride extended-release tablets whole.

ablets 1 time per day with or without food. Taking minocycline hydrochloride extended-release tablets with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. Swallow minocycline hydrochloride extended-release tablets whole. Do not chew, crush, or split the tablets. If you take too much minocycline hydrochloride extended-release tablets, stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider or go to the nearest hospital emergency room, or contact a poison control center right away at 1-800-222-1222. What should I avoid while taking minocycline hydrochloride extended-release tablets ? You should not drive or operate dangerous machinery until you know how minocycline hydrochloride extended-release tablets affects you. Minocycline hydrochloride extended-release tablets may cause you to feel dizzy or light-headed or have a spinning feeling (vertigo). Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with minocycline hydrochloride extended-release tablets. Minocycline hydrochloride extended-release tablets can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with minocycline hydrochloride extended-release tablets. What are possible side effects of minocycline hydrochloride extended-release tablets ? Minocycline hydrochloride extended-release tablets may cause serious side effects, including: Serious skin and allergic reactions have happened during treatment with minocycline. Minocycline hydrochloride extended-release tablets may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including: skin redness, rash, hives, sores in your mouth, or your skin blisters and peels swelling of your face, eyes, lips, tongue, or throat trouble swallowing or breathing blood in your urine fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine pain on the right side of the stomach area (abdominal pain) chest pain or abnormal heartbeats swelling in your legs, ankles, and feet Permanent tooth discoloration and problems with tooth enamel. Minocycline hydrochloride extended-release tablets may permanently turn a baby or child’s teeth yellow-gray-brown during tooth development. Minocycline hydrochloride extended-release tablets may also cause tooth enamel to not develop properly. You should not use minocycline hydrochloride extended-release tablets during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. See "What should I tell my healthcare provider before taking minocycline hydrochloride extended-release tablets?" Slow bone growth. Minocycline hydrochloride extended-release tablets may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with minocycline hydrochloride extended-release tablets. Diarrhea (antibiotic associated colitis). Antibiotic associated colitis can happen with most antibiotics, including minocycline hydrochloride extended-release tablets.

ants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with minocycline hydrochloride extended-release tablets. Diarrhea (antibiotic associated colitis). Antibiotic associated colitis can happen with most antibiotics, including minocycline hydrochloride extended-release tablets. This type of diarrhea may be caused by an infection (Clostridioides difficile) in your intestines and can be severe and can lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. Liver problems. Minocycline hydrochloride extended-release tablets may cause serious liver problems that can lead to death. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of liver problems: loss of appetite unexplained bleeding or bleeding more easily than normal tiredness diarrhea confusion yellowing of your skin or the whites of your eyes (jaundice) sleepiness Central nervous system effects. See "What should I avoid while taking minocycline hydrochloride extended-release tablets?" Central nervous system effects such as light-headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with minocycline hydrochloride extended-release tablets or if treatment is stopped. Increased pressure around the brain (idiopathic intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking minocycline hydrochloride extended-release tablets and tell your healthcare provider right away if you have blurred vision, double vision, vision loss, or unusual headaches. Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using minocycline hydrochloride extended-release tablets for a long time to treat acne may cause immune system reactions. Stop taking minocycline hydrochloride extended-release tablets and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness. Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking SOLODYN?” Discoloration (tissue hyperpigmentation). Minocycline hydrochloride extended-release tablets may cause darkening of your nails, skin, eyes, teeth, gums, scars, and internal organs. The most common side effects of minocycline hydrochloride extended-release tablets include: headache dizziness or spinning feeling tiredness itching Your healthcare provider may do blood tests and check you for side effects during treatment with minocycline hydrochloride extended-release tablets and may lower your dose or stop treatment if you develop certain side effects. These are not all of the possible side effects of minocycline hydrochloride extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bausch Health US, LLC at 1-800-321-4576. How should I store minocycline hydrochloride extended-release tablets ? Store minocycline hydrochloride extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep the minocycline hydrochloride extended-release tablets container tightly closed. Keep minocycline hydrochloride extended-release tablets away from light, moisture, and excessive heat. Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children. General information about the safe and effective use of minocycline hydrochloride extended-release tablets .

sed. Keep minocycline hydrochloride extended-release tablets away from light, moisture, and excessive heat. Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children. General information about the safe and effective use of minocycline hydrochloride extended-release tablets . Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give minocycline hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about minocycline hydrochloride extended-release tablets that is written for health professionals. What are the ingredients in minocycline hydrochloride extended-release tablets? Active ingredient: minocycline hydrochloride Inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 For more information, call 1-877-272-7901. This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: October 2025 PT 3278-04

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride. The 80 mg extended release tablets are Greyish brown colored capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: NDC 72162-1839-3: 30 Tablets in a Bottle 16.2 Storage Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. 16.3 Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Trademarks are the property of their respective owners. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8107873 Revised: February 2026

DESCRIPTION Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac. description

CLINICAL PHARMACOLOGY Following a single dose of two minocycline hydrochloride capsules, 100 mg administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours). When minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of minocycline hydrochloride capsules was unchanged compared to dosing under fasting conditions. The mean T max was delayed by 1 hour when administered with food, compared to dosing under fasting conditions. Minocycline hydrochloride capsules may be administered with or without food. In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines. Microbiology Mechanism of Action The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common. Antimicrobial Activity Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections (see INDICATIONS AND USAGE ). Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureus Streptococcus pneumoniae Gram-negative Bacteria Acinetobacter species Bartonella bacilliformis Brucella species Campylobacter fetus Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella aerogenes Klebsiella granulomatis Klebsiella species Neisseria gonorrhoeae Neisseria meningitidis Shigella species Yersinia pestis Vibrio cholerae Other Microorganisms Actinomyces species Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium species Entamoeba species Fusobacterium nucleatum subspecies fusiforme Mycobacterium marinum Mycoplasma pneumoniae Propionibacterium acnes Rickettsiae Treponema pallidum subspecies pallidum Treponema pallidum subspecies pertenue Ureaplasma urealyticum Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by the FDA for this drug, please see https://www.fda.gov/STIC.

INDICATIONS AND USAGE Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis . Psittacosis (Ornithosis) due to Chlamydophila psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis . Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis . Relapsing fever due to Borrelia recurrentis . Chancroid caused by Haemophilus ducreyi . Plague due to Yersinia pestis . Tularemia due to Francisella tularensis . Cholera caused by Vibrio cholerae . Campylobacter fetus infections caused by Campylobacter fetus . Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis . Granuloma inguinale caused by Klebsiella granulomatis . Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Klebsiella aerogenes Shigella species . Acinetobacter species . Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae . Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae . Syphilis caused by Treponema pallidum subspecies pallidum . Yaws caused by Treponema pallidum subspecies pertenue . Listeriosis due to Listeria monocytogenes . Anthrax due to Bacillus anthracis . Vincent’s infection caused by Fusobacterium fusiforme . Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.

gococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection . Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum . To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

WARNINGS Tooth Development Minocycline hydrochloride, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Use in Pregnancy Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. The safety of minocycline hydrochloride capsules for use during pregnancy has not been established. Dermatologic Reaction Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines (see ADVERSE REACTIONS ). If severe skin reactions occur, discontinue minocycline hydrochloride immediately and institute appropriate therapy. Antianabolic Action The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours (see DOSAGE AND ADMINISTRATION ). If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity. Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline. Central Nervous System Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

edness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Clostridium difficile -Associated Diarrhea Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including minocycline hydrochloride. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH. Concomitant use of isotretinoin and minocycline hydrochloride should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.

PRECAUTIONS General As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued, and appropriate therapy instituted. Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated. Prescribing minocycline hydrochloride capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline. Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS ). Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see PRECAUTIONS - Drug Interactions ). Patients should be counseled that antibacterial drugs including minocycline hydrochloride capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future. Unused supplies of tetracycline antibiotics should be discarded by the expiration date. Laboratory Tests In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed. Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

hs. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed. Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS ). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines. Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats. Pregnancy Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects : (see WARNINGS .) Labor and Delivery The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS ). Pediatric Use Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ). Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ). Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS and DOSAGE AND ADMINISTRATION ). Minocycline hydrochloride capsules (50 mg, 75 mg and 100 mg) do not contain sodium.

Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline. Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS ). Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see PRECAUTIONS - Drug Interactions ). Patients should be counseled that antibacterial drugs including minocycline hydrochloride capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future. Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future. Unused supplies of tetracycline antibiotics should be discarded by the expiration date. PATIENT INFORMATION MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride ) CAPSULES, USP 50 mg, 75 mg and 100 mg Rx only Read the Patient Information that comes with minocycline hydrochloride capsules, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. What are minocycline hydrochloride capsules, USP? Minocycline hydrochloride capsules, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules, USP may be used along with other treatments for severe acne. Sometimes other germs, called viruses, cause infections. The common cold is a virus. Minocycline hydrochloride capsules, USP, like other antibiotics, do not treat viruses. Who should not take minocycline hydrochloride capsules, USP? Do not take minocycline hydrochloride capsules, USP if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this Patient Information leaflet for a complete list of ingredients in minocycline hydrochloride capsules, USP. Minocycline hydrochloride capsules, USP are not recommended for pregnant women or children under 8 years of age because: 1. Minocycline hydrochloride capsules, USP may harm an unborn baby. 2. Minocycline hydrochloride capsules, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years. What should I tell my doctor before taking minocycline hydrochloride capsules, USP? Before taking minocycline hydrochloride capsules, USP, tell your doctor about all of your medical conditions, including if you: have liver or kidney problems. are pregnant or plan to become pregnant. Minocycline hydrochloride capsules, USP may harm your unborn baby. Stop taking minocycline hydrochloride capsules, USP and call your doctor if you become pregnant while taking it. are breastfeeding or plan to breastfeed. Minocycline passes into your breast milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride capsules, USP or breastfeed. You should not do both. Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using minocycline hydrochloride capsules, USP with other medicines can cause side effects. Especially tell your doctor if you take: birth control pills. Minocycline hydrochloride capsules, USP may make your birth control pills less effective. a blood thinner medicine. The dose of your blood thinner may have to be lowered. a penicillin antibiotic medicine. Minocycline hydrochloride capsules, USP and penicillins should not be used together. migraine medicines called ergot alkaloids. an acne medicine by mouth called isotretinoin. antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

should not be used together. migraine medicines called ergot alkaloids. an acne medicine by mouth called isotretinoin. antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine. How should I take minocycline hydrochloride capsules, USP? Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. Skipping doses or not taking all your minocycline hydrochloride capsules, USP may: Decrease the effectiveness of the treatment. Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP. Take minocycline hydrochloride capsules, USP with a full glass of liquid . Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. Minocycline hydrochloride capsules, USP may be taken with or without food. If you forget to take minocycline hydrochloride capsules, USP, take them as soon as you remember. If you take too much minocycline hydrochloride capsules, USP, call your doctor or poison control center right away. What are the possible side effects of minocycline hydrochloride capsules, USP? Minocycline hydrochloride capsules, USP may cause serious side effects. Stop minocycline hydrochloride capsules, USP and call your doctor if you have: watery diarrhea bloody stools stomach cramps unusual headaches blurred vision fever rash joint pain feeling very tired swollen lymph nodes Minocycline hydrochloride capsules, USP may also cause: central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms. sun sensitivity (photosensitivity). You may get a worse sunburn with minocycline hydrochloride capsules, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride capsules, USP and call your doctor if your skin turns red. These are not all the possible side effects of minocycline hydrochloride capsules, USP. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store minocycline hydrochloride capsules, USP? Store minocycline hydrochloride capsules, USP at room temperature between 68°F to 77°F (20°C to 25°C). Keep minocycline hydrochloride capsules, USP away from light, moisture, and excess heat. Throw away any minocycline hydrochloride capsules, USP that are outdated or no longer needed. Keep minocycline hydrochloride capsules, USP and all medicines out of the reach of children. General information about minocycline hydrochloride capsules, USP Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about minocycline hydrochloride capsules, USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride capsules, USP that is written for health professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561. What are the ingredients in minocycline hydrochloride capsules, USP?

alk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride capsules, USP that is written for health professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561. What are the ingredients in minocycline hydrochloride capsules, USP? Active ingredient: minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg Inactive ingredients: Corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac. Trademarks are the property of their respective owners. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8107874 Revised: February 2026 This Patient Information has been approved by the U.S. Food and Drug Administration.

Laboratory Tests In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed.

Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS ). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

Pregnancy Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects : (see WARNINGS .)

Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS ).

Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS and DOSAGE AND ADMINISTRATION ). Minocycline hydrochloride capsules (50 mg, 75 mg and 100 mg) do not contain sodium.

ADVERSE REACTIONS Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole : Fever and discoloration of secretions. Gastrointestinal : Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary : Vulvovaginitis. Hepatic toxicity : Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ). Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity ). Pigmentation of the skin and mucous membranes has been reported. Respiratory : Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis. Renal toxicity : Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS ). Reversible acute renal failure has been reported. Musculoskeletal : Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions : Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions also have been reported. Blood : Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported. Central Nervous System : Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see WARNINGS-Intracranial Hypertension ). Headache has also been reported. Other : Thyroid cancer has been reported in the postmarketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported. Tooth discoloration in children less than 8 years of age (see WARNINGS -Tooth Development ) and also in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride.

have been reported. Tooth discoloration in children less than 8 years of age (see WARNINGS -Tooth Development ) and also in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride. The following syndromes have been reported. In some cases, involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis. Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling and lymphadenopathy. Eosinophilia may be present. Post-Marketing Experience The following adverse reaction has been identified during post-approval use of minocycline products when taken orally. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions : Acute febrile neutrophilic dermatosis (Sweet’s syndrome). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharmaceuticals Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY ). Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. Adults The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum : 100 mg orally, every 12 hours for at least 7 days. Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the antianabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS - Antianabolic Action ).

HOW SUPPLIED Minocycline HCl Capsules, USP equivalent to 100 mg* minocycline with a gray opaque cap and white opaque body imprinted " RX 696 " on cap and body in black ink and supplied as follows: NDC 43063-736-14 Bottles of 14 NDC 43063-736-20 Bottles of 20 NDC 43063-736-30 Bottles of 30 NDC 43063-736-60 Bottles of 60 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container with child-resistant closure. * The appearance of the product may vary depending on the source of the ingredients filled in the capsule.

ANIMAL PHARMACOLOGY AND TOXICOLOGY Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

<table width="590px" border="1" cellspacing="0" cellpadding="0"><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">PATIENT INFORMATION</content></paragraph><paragraph><content styleCode="bold">MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride</content><content styleCode="bold">) CAPSULES, USP</content></paragraph><paragraph><content styleCode="bold">50 mg, 75 mg and 100 mg</content></paragraph><paragraph><content styleCode="bold">Rx only</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph>Read the Patient Information that comes with minocycline hydrochloride capsules, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What are minocycline hydrochloride capsules, USP?</content></paragraph><paragraph>Minocycline hydrochloride capsules, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules, USP may be used along with other treatments for severe acne.</paragraph><paragraph/><paragraph>Sometimes other germs, called viruses, cause infections. The common cold is a virus. Minocycline hydrochloride capsules, USP, like other antibiotics, do not treat viruses.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">Who should not take minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Do not take minocycline hydrochloride capsules, USP if you are allergic to minocycline or other tetracycline antibiotics.</content></paragraph><paragraph>Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this Patient Information leaflet for a complete list of ingredients in minocycline hydrochloride capsules, USP.</paragraph><paragraph/><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP are not recommended for pregnant women or children under 8 years of age because:</content></paragraph><paragraph><content styleCode="bold">1. Minocycline hydrochloride capsules, USP may harm an unborn baby.</content></paragraph><paragraph><content styleCode="bold">2. Minocycline hydrochloride capsules, USP may permanently turn a baby&#x2019;s or child&#x2019;s teeth yellow-gray-brown during tooth development.</content>Tooth development happens in the last half of pregnancy and birth to age 8 years.

ay harm an unborn baby.</content></paragraph><paragraph><content styleCode="bold">2. Minocycline hydrochloride capsules, USP may permanently turn a baby&#x2019;s or child&#x2019;s teeth yellow-gray-brown during tooth development.</content>Tooth development happens in the last half of pregnancy and birth to age 8 years. </paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What should I tell my doctor before taking minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Before taking minocycline hydrochloride capsules, USP, tell your doctor about all of your medical conditions, including if you:</content></paragraph><list listType="unordered"><item><content styleCode="bold">have liver or kidney problems.</content></item><item><content styleCode="bold">are pregnant or plan to become pregnant.</content>Minocycline hydrochloride capsules, USP may harm your unborn baby. <content styleCode="bold">Stop taking minocycline hydrochloride capsules, USP and call your doctor if you become pregnant while taking it.</content></item><item><content styleCode="bold">are breastfeeding or plan to breastfeed.</content>Minocycline passes into your breast milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride capsules, USP or breastfeed. You should not do both. </item></list><paragraph><content styleCode="bold">Tell your doctor about all the medicines you take</content>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using minocycline hydrochloride capsules, USP with other medicines can cause side effects. </paragraph><paragraph/><paragraph><content styleCode="bold">Especially tell your doctor if you take:</content></paragraph><list listType="unordered"><item><content styleCode="bold">birth control pills.</content>Minocycline hydrochloride capsules, USP may make your birth control pills less effective. </item><item><content styleCode="bold">a blood thinner medicine.</content>The dose of your blood thinner may have to be lowered. </item><item><content styleCode="bold">a penicillin antibiotic medicine.</content>Minocycline hydrochloride capsules, USP and penicillins should not be used together. </item><item><content styleCode="bold">migraine medicines called ergot alkaloids.</content></item><item><content styleCode="bold">an acne medicine by mouth called isotretinoin.</content></item><item><content styleCode="bold">antacids that contain aluminum, calcium, or magnesium, or iron-containing products.</content></item></list><paragraph>Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">How should I take minocycline hydrochloride capsules, USP?</content></paragraph><list listType="unordered"><item><content styleCode="bold">Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. </content>Skipping doses or not taking all your minocycline hydrochloride capsules, USP may: <list listType="unordered"><item>Decrease the effectiveness of the treatment.</item><item>Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP.</item></list></item><item><content styleCode="bold">Take minocycline hydrochloride capsules, USP with a full glass of liquid</content>. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.

em><content styleCode="bold">Take minocycline hydrochloride capsules, USP with a full glass of liquid</content>. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. </item><item><content styleCode="bold">Minocycline hydrochloride capsules, USP </content><content styleCode="bold">may be taken with or without food.</content>If you forget to take minocycline hydrochloride capsules, USP, take them as soon as you remember. </item><item>If you take too much minocycline hydrochloride capsules, USP, call your doctor or poison control center right away.</item></list></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What are the possible side effects of minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP may cause serious side effects. Stop minocycline hydrochloride capsules, USP and call your doctor if you have:</content></paragraph><list listType="unordered"><item>watery diarrhea</item><item>bloody stools</item><item>stomach cramps</item><item>unusual headaches</item><item>blurred vision</item><item>fever</item><item>rash</item><item>joint pain</item><item>feeling very tired</item><item>swollen lymph nodes</item></list><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP may also cause:</content></paragraph><list listType="unordered"><item><content styleCode="bold">central nervous system effects.</content>Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms. </item></list><list listType="unordered"><item><content styleCode="bold">sun sensitivity (photosensitivity).</content>You may get a worse sunburn with minocycline hydrochloride capsules, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride capsules, USP and call your doctor if your skin turns red. </item></list><paragraph>These are not all the possible side effects of minocycline hydrochloride capsules, USP. For more information ask your doctor or pharmacist.</paragraph><paragraph/><paragraph><content styleCode="bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">How should I store minocycline hydrochloride capsules, USP?</content></paragraph><list listType="unordered"><item>Store minocycline hydrochloride capsules, USP at room temperature between 68&#xB0;F to 77&#xB0;F (20&#xB0;C to 25&#xB0;C).</item><item>Keep minocycline hydrochloride capsules, USP away from light, moisture, and excess heat.</item><item>Throw away any minocycline hydrochloride capsules, USP that are outdated or no longer needed.</item><item><content styleCode="bold">Keep minocycline hydrochloride capsules, USP and all medicines out of the reach of children.</content></item></list></td></tr><tr><td valign="top"><paragraph><content styleCode="bold">General information about minocycline hydrochloride capsules, USP</content></paragraph><paragraph>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have.

cines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have. It may harm them.</paragraph><paragraph/><paragraph>This Patient Information leaflet summarizes the most important information about minocycline hydrochloride capsules, USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride capsules, USP that is written for health professionals.</paragraph><paragraph/><paragraph>For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561.</paragraph></td></tr><tr><td valign="top"><paragraph><content styleCode="bold">What are the ingredients in minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Active ingredient:</content> minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg </paragraph><paragraph><content styleCode="bold">Inactive ingredients:</content>Corn starch and magnesium stearate. </paragraph><paragraph>The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide.</paragraph><paragraph>The 75 mg and 100 mg capsule shells also contain black iron oxide.</paragraph><paragraph>The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</paragraph><paragraph/><paragraph>Trademarks are the property of their respective owners.</paragraph><paragraph/><paragraph><content styleCode="bold">Manufactured by:</content></paragraph><paragraph>Torrent Pharmaceuticals LTD., India.</paragraph><paragraph><content styleCode="bold">Manufactured for:</content></paragraph><paragraph>Torrent Pharma INC., Basking Ridge, NJ 07920.</paragraph><paragraph>8107874 Revised: February 2026</paragraph></td></tr></tbody></table>

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Trademarks are the property of their respective owners. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8100890 Revised: April 2025

DESCRIPTION Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.

alk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride capsules, USP that is written for health professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561. What are the ingredients in minocycline hydrochloride capsules, USP? Active ingredient: minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg Inactive ingredients: Corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac. Trademarks are the property of their respective owners. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8100982 Revised: April 2025 This Patient Information has been approved by the U.S. Food and Drug Administration.

HOW SUPPLIED Minocycline HCl Capsules, USP equivalent to 50 mg* minocycline are white opaque capsules imprinted " RX 694" on cap and body in black ink and supplied as follows: NDC: 72162-2573-1: 100 Capsules in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container with child-resistant closure. * The appearance of the product may vary depending on the source of the ingredients filled in the capsule. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

<table width="590px" border="1" cellspacing="0" cellpadding="0"><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">PATIENT INFORMATION </content></paragraph><paragraph><content styleCode="bold">MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride</content><content styleCode="bold">) CAPSULES, USP</content></paragraph><paragraph><content styleCode="bold">50 mg, 75 mg and 100 mg</content></paragraph><paragraph><content styleCode="bold">Rx only</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph>Read the Patient Information that comes with minocycline hydrochloride capsules, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What are minocycline hydrochloride capsules, USP?</content></paragraph><paragraph>Minocycline hydrochloride capsules, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules, USP may be used along with other treatments for severe acne.</paragraph><paragraph/><paragraph>Sometimes other germs, called viruses, cause infections. The common cold is a virus. Minocycline hydrochloride capsules, USP, like other antibiotics, do not treat viruses.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">Who should not take minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Do not take minocycline hydrochloride capsules, USP if you are allergic to minocycline or other tetracycline antibiotics.</content></paragraph><paragraph>Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this Patient Information leaflet for a complete list of ingredients in minocycline hydrochloride capsules, USP.</paragraph><paragraph/><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP are not recommended for pregnant women or children under 8 years of age because:</content></paragraph><paragraph><content styleCode="bold">1. Minocycline hydrochloride capsules, USP may harm an unborn baby.</content></paragraph><paragraph><content styleCode="bold">2. Minocycline hydrochloride capsules, USP may permanently turn a baby&#x2019;s or child&#x2019;s teeth yellow-gray-brown during tooth development.</content> Tooth development happens in the last half of pregnancy and birth to age 8 years.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What should I tell my doctor before taking minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Before taking minocycline hydrochloride capsules, USP, tell your doctor about all of your medical conditions, including if you:</content></paragraph><list listType="unordered"><item><content styleCode="bold">have liver or kidney problems.</content></item><item><content styleCode="bold">are pregnant or plan to become pregnant.

taking minocycline hydrochloride capsules, USP, tell your doctor about all of your medical conditions, including if you:</content></paragraph><list listType="unordered"><item><content styleCode="bold">have liver or kidney problems.</content></item><item><content styleCode="bold">are pregnant or plan to become pregnant. </content>Minocycline hydrochloride capsules, USP may harm your unborn baby.<content styleCode="bold"> Stop taking minocycline hydrochloride capsules, USP and call your doctor if you become pregnant while taking it.</content></item><item><content styleCode="bold">are breastfeeding or plan to breastfeed.</content> Minocycline passes into your breast milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride capsules, USP or breastfeed. You should not do both.</item></list><paragraph><content styleCode="bold">Tell your doctor about all the medicines you take</content>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using minocycline hydrochloride capsules, USP with other medicines can cause side effects.</paragraph><paragraph/><paragraph><content styleCode="bold">Especially tell your doctor if you take:</content></paragraph><list listType="unordered"><item><content styleCode="bold">birth control pills.</content> Minocycline hydrochloride capsules, USP may make your birth control pills less effective.</item><item><content styleCode="bold">a blood thinner medicine.</content> The dose of your blood thinner may have to be lowered.</item><item><content styleCode="bold">a penicillin antibiotic medicine.</content> Minocycline hydrochloride capsules, USP and penicillins should not be used together.</item><item><content styleCode="bold">migraine medicines called ergot alkaloids.</content></item><item><content styleCode="bold">an acne medicine by mouth called isotretinoin. </content></item><item><content styleCode="bold">antacids that contain aluminum, calcium, or magnesium, or iron-containing products.</content></item></list><paragraph>Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">How should I take minocycline hydrochloride capsules, USP?</content></paragraph><list listType="unordered"><item><content styleCode="bold">Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. </content>Skipping doses or not taking all your minocycline hydrochloride capsules, USP may:<list listType="unordered"><item>Decrease the effectiveness of the treatment.</item><item>Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP.</item></list></item><item><content styleCode="bold">Take minocycline hydrochloride capsules, USP with a full glass of liquid</content>. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus.

e to minocycline hydrochloride capsules, USP.</item></list></item><item><content styleCode="bold">Take minocycline hydrochloride capsules, USP with a full glass of liquid</content>. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.</item><item><content styleCode="bold">Minocycline hydrochloride capsules, USP </content><content styleCode="bold">may be taken with or without food.</content> If you forget to take minocycline hydrochloride capsules, USP, take them as soon as you remember.</item><item>If you take too much minocycline hydrochloride capsules, USP, call your doctor or poison control center right away.</item></list></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What are the possible side effects of minocycline hydrochloride capsules, USP?</content></paragraph><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP may cause serious side effects. Stop minocycline hydrochloride capsules, USP and call your doctor if you have:</content></paragraph><list listType="unordered"><item>watery diarrhea</item><item>bloody stools</item><item>stomach cramps</item><item>unusual headaches</item><item>blurred vision</item><item>fever</item><item>rash</item><item>joint pain</item><item>feeling very tired</item><item>swollen lymph nodes</item></list><paragraph><content styleCode="bold">Minocycline hydrochloride capsules, USP may also cause:</content></paragraph><list listType="unordered"><item><content styleCode="bold">central nervous system effects.</content> Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms. </item></list><list listType="unordered"><item><content styleCode="bold">sun sensitivity (photosensitivity).</content> You may get a worse sunburn with minocycline hydrochloride capsules, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride capsules, USP and call your doctor if your skin turns red.</item></list><paragraph>These are not all the possible side effects of minocycline hydrochloride capsules, USP. For more information ask your doctor or pharmacist.</paragraph><paragraph/><paragraph><content styleCode="bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">How should I store minocycline hydrochloride capsules, USP?</content></paragraph><list listType="unordered"><item>Store minocycline hydrochloride capsules, USP at room temperature between 68&#xB0;F to 77&#xB0;F (20&#xB0;C to 25&#xB0;C).</item><item>Keep minocycline hydrochloride capsules, USP away from light, moisture, and excess heat.</item><item>Throw away any minocycline hydrochloride capsules, USP that are outdated or no longer needed.</item><item><content styleCode="bold">Keep minocycline hydrochloride capsules, USP and all medicines out of the reach of children.</content></item></list></td></tr><tr><td valign="top"><paragraph><content styleCode="bold">General information about minocycline hydrochloride capsules, USP</content></paragraph><paragraph>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have.

cines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have. It may harm them.</paragraph><paragraph/><paragraph>This Patient Information leaflet summarizes the most important information about minocycline hydrochloride capsules, USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride capsules, USP that is written for health professionals.</paragraph><paragraph/><paragraph>For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561.</paragraph></td></tr><tr><td valign="top"><paragraph><content styleCode="bold">What are the ingredients in minocycline hydrochloride capsules, USP? </content></paragraph><paragraph><content styleCode="bold">Active ingredient:</content> minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg</paragraph><paragraph><content styleCode="bold">Inactive ingredients:</content> Corn starch and magnesium stearate.</paragraph><paragraph>The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide.</paragraph><paragraph>The 75 mg and 100 mg capsule shells also contain black iron oxide.</paragraph><paragraph>The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</paragraph><paragraph/><paragraph>Trademarks are the property of their respective owners.</paragraph><paragraph><content styleCode="bold"><renderMultiMedia referencedObject="Lb6d32ce6-80ae-4b8e-ba67-cdf10a2b0260"/></content></paragraph><paragraph><content styleCode="bold">Manufactured by:</content></paragraph><paragraph><content>Torrent Pharmaceuticals LTD., India.</content></paragraph><paragraph><content styleCode="bold">Manufactured for:</content></paragraph><paragraph><content>Torrent Pharma INC., Basking Ridge, NJ 07920.</content></paragraph><paragraph><content>8100982 Revised: April 2025</content></paragraph></td></tr></tbody></table>

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8107879 Revised: February 2026 image description

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8107879 Revised: February 2026 image description PATIENT INFORMATION PATIENT INFORMATION MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride ) TABLETS, USP 50 mg, 75 mg and 100 mg Rx only Read the Patient Information that comes with minocycline hydrochloride tablets, USP before you or a family member starts taking it and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. What are minocycline hydrochloride tablets, USP? Minocycline hydrochloride tablets, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride tablets, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride tablets, USP may be used along with other treatments for severe acne. Sometimes other germs, called viruses, cause infections. The common cold is a virus. Minocycline hydrochloride tablets, USP, like other antibiotics, does not treat viruses. Who should not take minocycline hydrochloride tablets, USP? Do not take minocycline hydrochloride tablets, USP if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this Patient Information leaflet for a complete list of ingredients in minocycline hydrochloride tablets, USP. Minocycline hydrochloride tablets, USP are not recommended for pregnant women or children under 8 years of age because: 1. Minocycline hydrochloride tablets, USP may harm an unborn baby. 2. Minocycline hydrochloride tablets, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years. What should I tell my doctor before taking minocycline hydrochloride tablets, USP? Before taking minocycline hydrochloride tablets, USP tell your doctor about all of your medical conditions, including if you: have liver or kidney problems. are pregnant or plan to become pregnant. Minocycline hydrochloride tablets, USP may harm your unborn baby. Stop taking minocycline hydrochloride tablets, USP and call your doctor if you become pregnant while taking it. are breastfeeding or plan to breastfeed. Minocycline passes into your breast milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride tablets, USP or breastfeed. You should not do both. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using minocycline hydrochloride tablets, USP with other medicines can cause side effects. Especially tell your doctor if you take: birth control pills. Minocycline hydrochloride tablets, USP may make your birth control pills less effective. a blood thinner medicine. The dose of your blood thinner may have to be lowered. a penicillin antibiotic medicine . Minocycline hydrochloride tablets, USP and penicillins should not be used together. migraine medicines called ergot alkaloids. an acne medicine by mouth called isotretinoin. antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

should not be used together. migraine medicines called ergot alkaloids. an acne medicine by mouth called isotretinoin. antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine. How should I take minocycline hydrochloride tablets, USP? Take minocycline hydrochloride tablets, USP exactly as your doctor tells you to take them . Skipping doses or not taking all your minocycline hydrochloride tablets, USP may: o Decrease the effectiveness of the treatment. o Increase the chance that bacteria will develop resistance to minocycline hydrochloride tablets, USP. Take minocycline hydrochloride tablets, USP with a full glass of liquid. Taking minocycline hydrochloride tablets, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. Minocycline hydrochloride tablets, USP may be taken with or without food. If you forget to take minocycline hydrochloride tablets, USP, take it as soon as you remember. If you take too much minocycline hydrochloride tablets, USP, call your doctor or poison control center right away. What are the possible side effects of minocycline hydrochloride tablets, USP? Minocycline hydrochloride tablets, USP may cause serious side effects. Stop minocycline hydrochloride tablets, USP and call your doctor if you have: watery diarrhea bloody stools stomach cramps unusual headaches blurred vision fever rash joint pain feeling very tired swollen lymph nodes Minocycline hydrochloride tablets, USP may also cause: central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms. sun sensitivity (photosensitivity). You may get a worse sunburn with minocycline hydrochloride tablets, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride tablets, USP and call your doctor if your skin turns red. These are not all the possible side effects of minocycline hydrochloride tablets, USP. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store minocycline hydrochloride tablets, USP? Store minocycline hydrochloride tablets, USP at room temperature between 68°F to 77°F (20°C to 25°C). Keep minocycline hydrochloride tablets, USP away from light, moisture, and excess heat. Throw away any minocycline hydrochloride tablets, USP that is outdated or no longer needed. Keep minocycline hydrochloride tablets, USP and all medicines out of the reach of children. General information about minocycline hydrochloride tablets, USP Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride tablets, USP for a condition for which it was not prescribed. Do not give minocycline hydrochloride tablets, USP to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about minocycline hydrochloride tablets, USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride tablets, USP that is written for health professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561. What are the ingredients in minocycline hydrochloride tablets, USP?

talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride tablets, USP that is written for health professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561. What are the ingredients in minocycline hydrochloride tablets, USP? Active ingredient: minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg Inactive ingredients : colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide. Trademarks are the property of their respective owners. Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8107880 Revised: February 2026 This Patient Information has been approved by the U.S. Food and Drug Administration. company-logo

DESCRIPTION Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Minocycline hydrochloride tablets, USP for oral administration, contains minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide. chemical-structure

CLINICAL PHARMACOLOGY Following a single dose of one 100 mg tablet of minocycline hydrochloride administered to 28 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 3 hours (average 1.71 hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL). The serum half-life in the normal volunteers ranged from 11.38 to 24.31 hours (average 17.03 hours). When minocycline hydrochloride tablets were given concomitantly with a meal, which included dairy products, the extent of absorption of minocycline hydrochloride tablets was slightly decreased (6%). The peak plasma concentrations were slightly decreased (12%) and delayed by 1.09 hours when administered with food, compared to dosing under fasting conditions. Minocycline hydrochloride tablets may be administered with or without food. In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines. Microbiology Mechanism of Action The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common. Antimicrobial Activity Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections (see INDICATIONS AND USAGE ). Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureus Streptococcus pneumoniae Gram-negative Bacteria Acinetobacter species Bartonella bacilliformis Brucella species Campylobacter fetus Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella aerogenes Klebsiella granulomatis Klebsiella species Neisseria gonorrhoeae Neisseria meningitidis Shigella species Yersinia pestis Vibrio cholerae Other Microorganisms Actinomyces species Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium species Entamoeba species Fusobacterium nucleatum subspecies fusiforme Mycobacterium marinum Mycoplasma pneumoniae Propionibacterium acnes Rickettsiae Treponema pallidum subspecies pallidum Treponema pallidum subspecies pertenue Ureaplasma urealyticum Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by the FDA for this drug, please see https://www.fda.gov/STIC.

INDICATIONS AND USAGE Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis . Cholera caused by Vibrio cholerae . Campylobacter fetus infections caused by Campylobacter fetus . Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis . Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Klebsiella aerogenes Shigella species . Acinetobacter species . Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species . Minocycline hydrochloride tablets, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus . (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae . Syphilis caused by Treponema pallidum subspecies pallidum . Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthraci s . Vincent’s infection caused by Fusobacterium fusiforme . Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.

gococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum . To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

WARNINGS Tooth Development Minocycline hydrochloride, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Use in Pregnancy Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. The safety of minocycline hydrochloride tablets for use during pregnancy has not been established. Dermatologic Reaction Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines (see ADVERSE REACTIONS ). If severe skin reactions occur, discontinue minocycline hydrochloride tablets immediately and institute appropriate therapy. Antianabolic Action The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours (see DOSAGE AND ADMINISTRATION ). If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity. Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline. Central Nervous System Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

edness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Clostridium difficile -Associated Diarrhea Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including minocycline hydrochloride. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH. Concomitant use of isotretinoin and minocycline hydrochloride should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.

PRECAUTIONS General As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued, and appropriate therapy instituted. Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated. Prescribing minocycline hydrochloride tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline. Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS ). Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see PRECAUTIONS - Drug Interactions ). Patients should be counseled that antibacterial drugs including minocycline hydrochloride tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride tablets or other antibacterial drugs in the future. Unused supplies of tetracycline antibiotics should be discarded by the expiration date. Laboratory Tests In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed. Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

hs. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed. Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS ). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines. Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats. Pregnancy Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects: (see WARNINGS .) Labor and Delivery The effect of tetracyclines on labor and delivery is unknown. Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS ). Pediatric Use Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ). Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ). Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS and DOSAGE AND ADMINISTRATION ).

ADVERSE REACTIONS Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole : Fever and discoloration of secretions. Gastrointestinal : Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary : Vulvovaginitis. Hepatic toxicity : Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ). Skin : Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity ). Pigmentation of the skin and mucous membranes has been reported. Respiratory : Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis. Renal toxicity : Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS ). Reversible acute renal failure has been reported. Musculoskeletal : Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions : Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions also have been reported. Blood : Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported. Central Nervous System : Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see WARNINGS-Intracranial Hypertension ). Headache has also been reported. Other : Thyroid cancer has been reported in the postmarketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported. Tooth discoloration in children less than 8 years of age (see WARNINGS-Tooth Development ) and also in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride.

n have been reported. Tooth discoloration in children less than 8 years of age (see WARNINGS-Tooth Development ) and also in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride. The following syndromes have been reported. In some cases, involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis. Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling and lymphadenopathy. Eosinophilia may be present. Post-Marketing Experience The following adverse reaction has been identified during post-approval use of minocycline products when taken orally. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions : Acute febrile neutrophilic dermatosis (Sweet’s syndrome). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharmaceuticals Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride tablets may be taken with or without food (see CLINICAL PHARMACOLOGY ). Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The tablets should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. Adults The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg tablet 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum : 100 mg orally, every 12 hours for at least 7 days. Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the antianabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS-Antianabolic Action ).

HOW SUPPLIED Minocycline hydrochloride tablets, USP equivalent to 50 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “ RI89 ” on one side and plain on the other side. They are supplied as follows: NDC 13668-485-01 Bottles of 100 Minocycline hydrochloride tablets, USP equivalent to 75 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “ RI90 ” on one side and plain on the other side. They are supplied as follows: NDC 13668-486-01 Bottles of 100 Minocycline hydrochloride tablets, USP equivalent to 100 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “ RI91 ” on one side and plain on the other side. They are supplied as follows: NDC 13668-487-50 Bottles of 50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container with child-resistant closure.

ANIMAL PHARMACOLOGY AND TOXICOLOGY Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs. Trademarks are the property of their respective owners.

<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">PATIENT INFORMATION </content></paragraph><paragraph><content styleCode="bold">MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride</content><content styleCode="bold">) TABLETS, USP</content></paragraph><paragraph><content styleCode="bold">50 mg, 75 mg and 100 mg</content></paragraph><paragraph><content styleCode="bold">Rx only</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph>Read the Patient Information that comes with minocycline hydrochloride tablets, USP before you or a family member starts taking it and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">What are minocycline hydrochloride tablets, USP?</content><paragraph>Minocycline hydrochloride tablets, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride tablets, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride tablets, USP may be used along with other treatments for severe acne.</paragraph><paragraph/><paragraph>Sometimes other germs, called viruses, cause infections. The common cold is a virus. Minocycline hydrochloride tablets, USP, like other antibiotics, does not treat viruses.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Who should not take minocycline hydrochloride tablets, USP?</content><paragraph><content styleCode="bold">Do not take minocycline hydrochloride tablets, USP if you are allergic to minocycline or other tetracycline antibiotics.</content></paragraph><paragraph>Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this Patient Information leaflet for a complete list of ingredients in minocycline hydrochloride tablets, USP.</paragraph><paragraph><content styleCode="bold">Minocycline hydrochloride tablets, USP are not recommended for pregnant women or children under 8 years of age because:</content></paragraph><paragraph><content styleCode="bold">1. </content><content styleCode="bold">Minocycline hydrochloride tablets, USP may harm an unborn baby.</content></paragraph><paragraph><content styleCode="bold">2. </content><content styleCode="bold">Minocycline hydrochloride tablets, USP may permanently turn a baby&#x2019;s or child&#x2019;s teeth yellow-gray-brown during tooth development.

tyleCode="bold">Minocycline hydrochloride tablets, USP may harm an unborn baby.</content></paragraph><paragraph><content styleCode="bold">2. </content><content styleCode="bold">Minocycline hydrochloride tablets, USP may permanently turn a baby&#x2019;s or child&#x2019;s teeth yellow-gray-brown during tooth development. </content>Tooth development happens in the last half of pregnancy and birth to age 8 years.</paragraph><paragraph/></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What should I tell my doctor before taking minocycline hydrochloride tablets, USP?</content></paragraph><paragraph><content styleCode="bold">Before taking minocycline hydrochloride tablets, USP tell your doctor about all of your medical conditions, including if you:</content></paragraph><list listType="unordered"><item><content styleCode="bold">have liver or kidney problems.</content></item><item><content styleCode="bold">are pregnant or plan to become pregnant.</content> Minocycline hydrochloride tablets, USP may harm your unborn baby. <content styleCode="bold">Stop taking minocycline hydrochloride tablets, USP and call your doctor if you become pregnant while taking it.</content></item><item><content styleCode="bold">are breastfeeding or plan to breastfeed.</content> Minocycline passes into your breast milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride tablets, USP or breastfeed. You should not do both.</item></list><paragraph><content styleCode="bold">Tell your doctor about all the medicines you take,</content> including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using minocycline hydrochloride tablets, USP with other medicines can cause side effects.</paragraph><paragraph><content styleCode="bold">Especially tell your doctor if you take:</content></paragraph><list listType="unordered"><item><content styleCode="bold">birth control pills. </content>Minocycline hydrochloride tablets, USP may make your birth control pills less effective.</item><item><content styleCode="bold">a blood thinner medicine. </content>The dose of your blood thinner may have to be lowered.</item><item><content styleCode="bold">a penicillin antibiotic medicine</content>. Minocycline hydrochloride tablets, USP and penicillins should not be used together.</item><item><content styleCode="bold">migraine medicines called ergot alkaloids.</content></item><item><content styleCode="bold">an acne medicine by mouth called isotretinoin.</content></item><item><content styleCode="bold">antacids that contain aluminum, calcium, or magnesium, or iron-containing products.</content></item></list><paragraph>Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">How should I take minocycline hydrochloride tablets, USP?</content><list listType="unordered"><item><content styleCode="bold">Take minocycline hydrochloride tablets, USP exactly as your doctor tells you to take them</content>. Skipping doses or not taking all your minocycline hydrochloride tablets, USP may: o Decrease the effectiveness of the treatment. o Increase the chance that bacteria will develop resistance to minocycline hydrochloride tablets, USP.</item><item><content styleCode="bold">Take minocycline hydrochloride tablets, USP with a full glass of liquid. </content>Taking minocycline hydrochloride tablets, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus.

develop resistance to minocycline hydrochloride tablets, USP.</item><item><content styleCode="bold">Take minocycline hydrochloride tablets, USP with a full glass of liquid. </content>Taking minocycline hydrochloride tablets, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.</item><item><content styleCode="bold">Minocycline hydrochloride tablets, USP </content><content styleCode="bold">may be taken with or without food.</content> If you forget to take minocycline hydrochloride tablets, USP, take it as soon as you remember.</item><item>If you take too much minocycline hydrochloride tablets, USP, call your doctor or poison control center right away.</item></list></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">What are the possible side effects of minocycline hydrochloride tablets, USP?</content><paragraph><content styleCode="bold">Minocycline hydrochloride tablets, USP may cause serious side effects. Stop minocycline hydrochloride tablets, USP and call your doctor if you have:</content></paragraph><list listType="unordered"><item>watery diarrhea</item><item>bloody stools</item><item>stomach cramps</item><item>unusual headaches</item><item>blurred vision</item><item>fever</item><item>rash</item><item>joint pain</item><item>feeling very tired</item><item>swollen lymph nodes</item></list><content styleCode="bold">Minocycline hydrochloride tablets, USP may also cause:</content> <list listType="unordered"><item><content styleCode="bold">central nervous system effects.</content> Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms.</item><item><content styleCode="bold">sun sensitivity (photosensitivity).</content> You may get a worse sunburn with minocycline hydrochloride tablets, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride tablets, USP and call your doctor if your skin turns red.</item></list>These are not all the possible side effects of minocycline hydrochloride tablets, USP. For more information ask your doctor or pharmacist.<paragraph><content styleCode="bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">How should I store minocycline hydrochloride tablets, USP?</content><list listType="unordered"><item>Store minocycline hydrochloride tablets, USP at room temperature between 68&#xB0;F to 77&#xB0;F (20&#xB0;C to 25&#xB0;C).</item><item>Keep minocycline hydrochloride tablets, USP away from light, moisture, and excess heat.</item><item>Throw away any minocycline hydrochloride tablets, USP that is outdated or no longer needed.</item><item><content styleCode="bold">Keep minocycline hydrochloride tablets, USP and all medicines out of the reach of children.</content></item></list></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">General information about minocycline hydrochloride tablets, USP</content><paragraph>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take minocycline hydrochloride tablets, USP for a condition for which it was not prescribed. Do not give minocycline hydrochloride tablets, USP to other people, even if they have the same symptoms you have. It may harm them.</paragraph><paragraph/><paragraph>This Patient Information leaflet summarizes the most important information about minocycline hydrochloride tablets, USP.

for which it was not prescribed. Do not give minocycline hydrochloride tablets, USP to other people, even if they have the same symptoms you have. It may harm them.</paragraph><paragraph/><paragraph>This Patient Information leaflet summarizes the most important information about minocycline hydrochloride tablets, USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride tablets, USP that is written for health professionals.</paragraph><paragraph/><paragraph>For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561.</paragraph><paragraph/></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">What are the ingredients in minocycline hydrochloride tablets, USP?</content></paragraph><paragraph><content styleCode="bold">Active ingredient:</content> minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg</paragraph><paragraph><content styleCode="bold">Inactive ingredients</content>: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide.</paragraph><paragraph/><paragraph>Trademarks are the property of their respective owners.</paragraph><paragraph/><paragraph><renderMultiMedia referencedObject="L715c53ea-5620-45e1-89ae-a554d0f6f9b8"/></paragraph><paragraph><content styleCode="bold">Manufactured by:</content></paragraph><paragraph><content>Torrent Pharmaceuticals LTD., India.</content></paragraph><paragraph/><paragraph><content styleCode="bold">Manufactured for:</content></paragraph><paragraph><content>Torrent Pharma INC., Basking Ridge, NJ 07920.</content></paragraph><paragraph/><paragraph>8107880 Revised: February 2026</paragraph></td></tr></tbody></table>