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Flexible Plastic Container Rx only INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication 1. Prepare additive port. 2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. 3. The additive port may be protected by covering with an additive cap. 4. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) 1. Close flow control clamp of administration set. 2. Remove cover from outlet port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber. 6. Open flow control clamp and clear air from set. Close clamp. 7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 8. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections.

DESCRIPTION Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

CLINICAL PHARMACOLOGY When administered intravenously, these solutions provide a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

WARNINGS Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

PRECAUTIONS General Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother. Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency. Geriatric Use Clinical studies of Sodium Chloride Injection, USP 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 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 of concomitant disease or drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section).

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table. NDC No. Product Container size mL 0409-7730-36 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0.45% Sodium Chloride Inj., USP 50 0990-7730-36 0.45% Sodium Chloride Inj., USP 50 0409-7730-37 0.45% Sodium Chloride Inj., USP 100 0990-7730-37 0.45% Sodium Chloride Inj., USP 100 0409-7985-02 0.45% Sodium Chloride Inj., USP 250 0990-7985-02 0.45% Sodium Chloride Inj., USP 250 0409-7985-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0.45% Sodium Chloride Inj., USP 500 0990-7985-03 , 0.45% Sodium Chloride Inj., USP 500 0409-7985-09 , 0.45% Sodium Chloride Inj., USP 1000 0990-7985-09 , 0.45% Sodium Chloride Inj., USP 1000 0409-7984-20 0.9% Sodium Chloride Inj., USP 25 0990-7984-20 0.9% Sodium Chloride Inj., USP 25 0409-7984-36 0.9% Sodium Chloride Inj., USP 50 0990-7984-36 0.9% Sodium Chloride Inj., USP 50 0409-7984-13 0.9% Sodium Chloride Inj., USP 50 0990-7984-13 0.9% Sodium Chloride Inj., USP 50 0409-7984-37 0.9% Sodium Chloride Inj., USP 100 0990-7984-37 0.9% Sodium Chloride Inj., USP 100 0409-7984-23 0.9% Sodium Chloride Inj., USP 100 0990-7984-23 0.9% Sodium Chloride Inj., USP 100 0409-7983-61 0.9% Sodium Chloride Inj., USP 150 0990-7983-61 0.9% Sodium Chloride Inj., USP 150 0409-7983-02 , 0.9% Sodium Chloride Inj., USP 250 0990-7983-02 , 0.9% Sodium Chloride Inj., USP 250 0409-7983-53 0.9% Sodium Chloride Inj., USP 250 0990-7983-53 0.9% Sodium Chloride Inj., USP 250 0409-7983-03 0.9% Sodium Chloride Inj., USP 500 0990-7983-03 , 0.9% Sodium Chloride Inj., USP 500 0409-7983-55 0.9% Sodium Chloride Inj., USP 500 0990-7983-55 0.9% Sodium Chloride Inj., USP 500 0409-7983-09 , 0.9% Sodium Chloride Inj., USP 1000 0990-7983-09 , 0.9% Sodium Chloride Inj., USP 1000 ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2020 IFU0000188

<table width="100%"><col width="29%" align="left" valign="middle"/><col width="41%" align="left" valign="middle"/><col width="29%" align="left" valign="middle"/><thead><tr><th align="left" styleCode="Botrule Toprule " valign="bottom"><content styleCode="bold">NDC No.</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Product</content></th><th align="center" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Container size mL</content></th></tr></thead><tbody><tr><td><paragraph>0409-7730-36<footnote ID="F1">Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA</footnote></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0990-7730-36<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0409-7730-37<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0990-7730-37<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0409-7985-02<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0990-7985-02<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0409-7985-03<footnote ID="F2">Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA</footnote></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0990-7985-03<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0409-7985-09<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>1000</paragraph></td></tr><tr><td><paragraph>0990-7985-09<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.45% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>1000</paragraph></td></tr><tr><td><paragraph>0409-7984-20<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>25</paragraph></td></tr><tr><td><paragraph>0990-7984-20<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>25</paragraph></td></tr><tr><td><paragraph>0409-7984-36<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0990-7984-36<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0409-7984-13<footnoteRef IDREF=

Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0990-7984-36<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0409-7984-13<footnoteRef IDREF= "F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0990-7984-13<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph>0409-7984-37<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0990-7984-37<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0409-7984-23<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0990-7984-23<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>100</paragraph></td></tr><tr><td><paragraph>0409-7983-61<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>150</paragraph></td></tr><tr><td><paragraph>0990-7983-61<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>150</paragraph></td></tr><tr><td><paragraph>0409-7983-02<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0990-7983-02<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0409-7983-53<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0990-7983-53<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>250</paragraph></td></tr><tr><td><paragraph>0409-7983-03<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0990-7983-03<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0409-7983-55<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0990-7983-55<footnoteRef IDREF="F1"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>500</paragraph></td></tr><tr><td><paragraph>0409-7983-09<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>1000</paragraph></td></tr><tr><td styleCode="Botrule "><paragraph>0990-7983-09<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td styleCode="Botrule "><paragraph>0.9% S

IDREF="F2"/></paragraph></td><td><paragraph>0.9% Sodium Chloride Inj., USP</paragraph></td><td align="center"><paragraph>1000</paragraph></td></tr><tr><td styleCode="Botrule "><paragraph>0990-7983-09<footnoteRef IDREF="F1"/>^,<footnoteRef IDREF="F2"/></paragraph></td><td styleCode="Botrule "><paragraph>0.9% S odium Chloride Inj., USP</paragraph></td><td align="center" styleCode="Botrule "><paragraph>1000</paragraph></td></tr></tbody></table>

DESCRIPTION Each 100 mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH: 5.6 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154 Each 100 mL of 0.45% Sodium Chloride Injection USP contains: Sodium Chloride USP 0.45 g; Water for Injection USP qs pH: 5.6 (4.5–7.0) Calculated Osmolarity: 155 mOsmol/liter, hypotonic pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 77 Chloride 77 Sodium Chloride Injections USP are sterile, nonpyrogenic, isotonic and contain no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

<table><col/><col/><col/><thead><tr><th align="center" valign="top"> Ingredient</th><th align="center" valign="top"> Molecular Formula</th><th align="center" valign="top"> Molecular Weight</th></tr><tr><th align="center" valign="top" styleCode=" Botrule" colspan="3"/></tr></thead><tbody><tr><td align="center" valign="top"> Sodium Chloride USP</td><td align="center" valign="top"> NaCl</td><td align="center" valign="top"> 58.44</td></tr></tbody></table>

CLINICAL PHARMACOLOGY Sodium Chloride Injections USP provide electrolytes and are a source of water for hydration. They are capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

INDICATIONS AND USAGE These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. 0.45% Sodium Chloride Injection USP is primarily a hydrating solution and may be used to assess the status of the kidneys, since more water is provided than is required for excretion of salt. It may also be used in the treatment of hyperosmolar diabetes where the use of dextrose is inadvisable and there is a need for large amounts of fluid without an excess of sodium ions. Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.

PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. Do not use plastic containers in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Sodium Chloride Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injections USP. It is also not known whether Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injections USP are administered to a nursing woman.

ity. Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injections USP are administered to a nursing woman. Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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 of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. Do not use plastic containers in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact.

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Sodium Chloride Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injections USP. It is also not known whether Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed.

Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Sodium Chloride Injections USP. It is also not known whether Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injections USP are administered to a nursing woman.

Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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 of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION These solutions are for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride). There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use .) Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures. When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case; the 500 mL and 250 mL containers are packaged 24 per case. NDC REF Size 0.9% Sodium Chloride Injection USP (Canada DIN 01924303) 0264-7800-00 L8000 1000 mL 0264-7800-10 L8001 500 mL 0264-7800-20 L8002 250 mL 0.45% Sodium Chloride Injection USP (Canada DIN 01927949) 0264-7802-00 L8020 1000 mL 0264-7802-10 L8021 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

<table><col/><col/><col/><thead><tr><th align="center" valign="top"> NDC</th><th align="center" valign="top"> REF</th><th align="center" valign="top"> Size</th></tr></thead><tbody><tr><td valign="top" colspan="3"> 0.9% Sodium Chloride Injection USP (Canada DIN 01924303)</td></tr><tr><td align="center" valign="top"> 0264-7800-00</td><td align="center" valign="top"> L8000</td><td align="center" valign="top"> 1000 mL</td></tr><tr><td align="center" valign="top"> 0264-7800-10</td><td align="center" valign="top"> L8001</td><td align="center" valign="top"> 500 mL</td></tr><tr><td align="center" valign="top"> 0264-7800-20</td><td align="center" valign="top"> L8002</td><td align="center" valign="top"> 250 mL</td></tr><tr><td valign="top" colspan="3"> 0.45% Sodium Chloride Injection USP (Canada DIN 01927949)</td></tr><tr><td align="center" valign="top"> 0264-7802-00</td><td align="center" valign="top"> L8020</td><td align="center" valign="top"> 1000 mL</td></tr><tr><td align="center" valign="top"> 0264-7802-10</td><td align="center" valign="top"> L8021</td><td align="center" valign="top"> 500 mL</td></tr></tbody></table>

Rx only Revised: January 2015 EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y36-002-882 LD-495-1

Directions for Use of EXCEL® Container Caution: Do not use plastic containers in series connection. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. NOTE : Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set. To Add Medication Warning: Some additives may be incompatible. To Add Medication Before Solution Administration Prepare medication site. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. To Add Medication During Solution Administration Close clamp on the set. Prepare medication site. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by tapping and squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration.

Description Sodium Chloride Injection, USP, 23.4%, is a concentrated, nonisotonic, sterile, nonpyrogenic solution of sodium chloride 234 mg in Water for Injection. pH adjusted with sodium hydroxide or hydrochloric acid if necessary. Sodium chloride is an electrolyte replenisher. It occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water; it is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

Clinical Pharmacology Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Both its ions are physiologically important. Sodium, more than any other ion, determines the osmotic pressure of interstitial fluids and the degree of hydration of tissues. When the intake of the chloride ion is less than is excreted, there is a relative increase in the blood bicarbonate level, producing the condition known as alkalosis. Other symptoms of sodium chloride deficiency are nausea, vomiting and increased irritability of muscles, evidenced by cramps and, possibly, convulsions. It is well known that excessive sweating will cause ‘‘heatcramps,’’ i.e., muscle cramps in the abdomen and extremities, which can be completely relieved only by ingestion of a weak salt solution. Approximately 25% of the total body sodium is found in the bone. The regulation of salt and water metabolism is governed by different mechanisms; however, changes in the intake, distribution and output of salt are, in health, associated with collateral shifts of water so that electrolyte concentrations are maintained within a narrow range. In the presence of disease affecting the cardiovascular, hepatic or renal system or in certain endocrinologic disorders, changes in the rate of excretion of salt and water will disturb the homeostatic equilibrium. Frequently, abnormalities in the metabolism of water or salt may occur as a result of vomiting, diarrhea, gastrointestinal suction and fever. Excessive sweating will produce loss of water or salt, but since the electrolyte concentration is hypotonic, loss of water will predominate. The normal salt intake ranges from 5 to 15 grams daily, most of which is excreted by the kidneys. The control of water and salt excretion in urine is very intricate, involving filtration by the glomerulus and reabsorption by the tubules of approximately 99% of the filtered load. The actual quantities excreted depends on the requirements prevailing at the moment. The finer adjustments of the tubular absorptive mechanisms are influenced by osmotic interrelationships between cell water, plasma and urine and by certain steroid hormones influencing electrolyte excretion and the posterior pituitary hormone regulating water excretion. When food intake ceases or salt is withheld, the content of sodium chloride in urine diminishes rapidly so that the body stores are retained. Similar renal retention of electrolytes occurs when salt is lost via gastrointestinal secretion through vomiting, etc. In other conditions, such as congestive heart failure, cirrhosis, nephritis or hypersecretion of the adrenal cortical hormones, the kidney fails to eliminate sufficient sodium. This results in retention of both salt and water, producing an excessive accumulation of extracellular fluid, which may be effectively combated by a sharp restriction of salt intake and use of a diuretic. Depletion of body salt may be caused in many ways, one of which is too energetic treatment of fluid and sodium retention. Besides this, diabetic acidosis, burns, excessive sweating with free drinking of water, repeated paracentesis for removal of ascitic fluid, adrenal cortical hypofunction and certain forms of nephritis, as well as abnormal losses of gastrointestinal secretions, will cause marked salt depletion. With salt loss, there is a reduction of the osmotic pressure of the extracellular fluid; the urine volume may be retained but it is free of sodium chloride.

Indications and Usage Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. The toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect. Symptoms of sodium chloride deficiency are very similar to those of Addison’s disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. Other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.

Contraindications Surgical patients should seldom receive salt- containing solutions immediately following surgery unless factors producing salt depletion are present. Because of renal retention of salt during surgery, additional electrolyte given intravenously may result in fluid retention, edema and overloading of the circulation.

Warnings This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Sodium Chloride Injection, USP, 23.4% is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis and cortical necrosis of the kidneys.

Precautions General Excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. Pregnancy Animal reproduction studies have not been conducted with Sodium Chloride Injection. It is also not known whether Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether sodium chloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection is administered to a nursing woman. Use in Children Safety and effectiveness in children have not been established.

Adverse Reactions Parenteral administration of quantities of sodium in excess of the amount of water or sodium chloride needed or at a rate more rapid than can be accommodated by the patient’s circulatory function may result in edema and clinical findings resembling those of congestive heart failure. Adverse effects are particularly likely to develop in patients with impaired renal or cardiac function. Signs of postoperative salt intolerance include cellular dehydration, weakness, disorientation, anorexia, nausea, distention, deep respiration, oliguria and increased blood urea nitrogen.

Overdosage Administration of too much sodium chloride may result in serious electrolyte disturbances with resulting retention of water, edema, loss of potassium and aggravation of an existing acidosis. When intake of sodium chloride is excessive, excretion of crystalloids is increased in an attempt to maintain normal osmotic pressure. Thus there is increased excretion of potassium and of bicarbonate and, consequently, a tendency toward acidosis. There is also a rapid elimination of any foreign salt, such as iodide and bromide, being used for therapy.

Dosage and Administration The dosage of Sodium Chloride Injection, USP, 23.4%, as an additive in parenteral fluid therapy is predicated on specific requirements of the patient after necessary clinical and laboratory information is considered and correlated. The appropriate volume is then withdrawn for proper dilution. Having determined the milliequivalents of sodium chloride to be added, divide by four to calculate the numbers of milliliters (mL) of sodium chloride to be used. Withdraw this volume aseptically and transfer the additive solution into appropriate intravenous solutions such as 5% Dextrose Injection. The properly diluted solutions may be given intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied Sodium Chloride Injection, USP, 23.4% is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. The container closure is not made with natural rubber latex. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 63323-093-30 30 mL fill in a 50 mL Single-dose Plastic Fliptop Vial Unit of 25 NDC 0404-9978-30 1 30 mL Single-dose Plastic Fliptop Vial in a bag (Vial bears NDC 63323-093-01) 23.4% 120 mEq/30 mL (4 mEq/mL) image2.jpg

<table width="100%"><caption> Product repackaged by: Henry Schein, Inc., Bastian, VA 24314</caption><tbody><tr><td>From Original Manufacturer/Distributor&apos;s NDC and Unit of Sale</td><td>To Henry Schein Repackaged Product NDC and Unit of Sale </td><td>Total Strength/Total Volume (Concentration) per unit </td></tr><tr><td>NDC 63323-093-30 30 mL fill in a 50 mL Single-dose Plastic Fliptop Vial Unit of 25</td><td>NDC 0404-9978-30 1 30 mL Single-dose Plastic Fliptop Vial in a bag (Vial bears NDC 63323-093-01)</td><td>23.4% 120 mEq/30 mL (4 mEq/mL)</td></tr></tbody></table>

CONCENTRATE CAUTION: MUST BE DILUTED FOR I.V. USE 14.6% Sodium Chloride Injection, USP Rx only 50 mEq/20 mL or 100 mEq/40 mL (2.5 mEq/mL) Additive Solution Concentrated Solution — For use only after dilution with compatible I.V. fluids to correct sodium deficiency when oral replacement is not feasible. Plastic Vial

<table width="100%"><col width="98%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph> <content styleCode="emphasis"><content styleCode="bold">CONCENTRATE</content></content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph> <content styleCode="emphasis"><content styleCode="italics">CAUTION: MUST BE DILUTED FOR I.V. USE</content></content></paragraph></td></tr></tbody></table>

DESCRIPTION 14.6% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either 2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Na + and Cl ¯ ) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 5 mOsmol/mL (calc.); specific gravity is 1.10. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl ¯ ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. Sodium is the principal cation of extracellular fluid. It comprises more than 90% of the total cations at its normal plasma concentration of approximately 142 mEq/liter. While the sodium ion can diffuse across cell membranes, intracellular sodium is maintained at a much lower concentration than extracellular sodium through the expenditure of energy by the cell (so called "sodium cation pump"). Loss of intracellular potassium ion is usually accompanied by an increase in intracellular sodium ion. When serum sodium concentration is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited, thereby preventing water reabsorption by the distal renal tubules. On the other hand, adrenal secretion of aldosterone increases renal tubular reabsorption of sodium in an effort to re-establish normal serum sodium concentration. Chloride (Cl ¯ ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl ¯ ) are largely under the control of the kidney which maintains a balance between intake and output.

INDICATIONS AND USAGE 14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.

WARNINGS 14.6% Sodium Chloride Injection, USP is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly). Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overload resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS 14.6% Sodium Chloride Injection, USP Additive Solution must be diluted before infusion to avoid a sudden increase in the level of plasma sodium. Too rapid administration should be avoided. Special caution should be used in administering sodium containing solutions to patients with severe renal impairment, cirrhosis of the liver, cardiac failure, or other edematous or sodium-retaining states. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Do not use unless the solution is clear and seal is intact. Discard unused portion. Pregnancy Animal reproduction studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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 of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Pediatric Use The safety and effectiveness of 14.6% Sodium Chloride Injection, USP Additive Solution have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

DOSAGE AND ADMINISTRATION 14.6% Sodium Chloride Injection, USP Additive Solution is administered intravenously only after addition to a larger volume of fluid. The dose, dilution and rate of injection are dependent upon the individual needs of each patient. All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED 14.6% Sodium Chloride Injection, USP Additive Solution is supplied as the following: Unit of Sale Concentration Each NDC 0409-6657-73 Tray of 25 50 mEq/20 mL (2.5 mEq/mL) NDC 0409-6657-01 20 mL Single-dose Plastic Fliptop Vial NDC 0409-6660-75 Tray of 25 100 mEq/40 mL (2.5 mEq/mL) NDC 0409-6660-01 40 mL Single-dose Plastic Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1099-1.0 9/2017 Hospira logo

<table width="100%"><col width="32%"/><col width="26%"/><col width="42%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="bottom"><paragraph><content styleCode="emphasis"><content styleCode="bold">Unit of Sale</content></content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="emphasis"><content styleCode="bold">Concentration</content></content></paragraph></td><td styleCode="Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="emphasis"><content styleCode="bold">Each</content></content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="emphasis"><content styleCode="bold">NDC 0409-6657-73</content></content></paragraph><paragraph>Tray of 25</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>50 mEq/20 mL</paragraph><paragraph>(2.5 mEq/mL)</paragraph></td><td styleCode="Lrule Botrule " valign="top"><paragraph>NDC 0409-6657-01</paragraph><paragraph>20 mL Single-dose Plastic Fliptop Vial</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="emphasis"><content styleCode="bold">NDC 0409-6660-75</content></content></paragraph><paragraph>Tray of 25</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>100 mEq/40 mL</paragraph><paragraph>(2.5 mEq/mL)</paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>NDC 0409-6660-01</paragraph><paragraph>40 mL Single-dose Plastic Fliptop Vial</paragraph></td></tr></tbody></table>

DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl‾) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na + ) and chloride (Cl‾) are largely under the control of the kidney which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

PRECAUTIONS Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy: Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.

ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS .

DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Unit of Sale Concentration NDC 0409-1918-32 Tub of 50 Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe System 0.9% (2 mL) NDC 0409-1918-33 Tub of 25 Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe System 0.9% (3 mL) NDC 0409-1918-35 Tub of 25 Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe System 0.9% (5 mL) NDC 0409-4888-90 Tray of 10 Single-dose Plastic Fliptop Vials 0.9% (10 mL) NDC 0409-4888-10 Tray of 25 Single-dose Plastic Fliptop Vials 0.9% (10 mL) NDC 0409-4888-20 Tray of 25 Single-dose Plastic Fliptop Vials 0.9% (20 mL) NDC 0409-4888-50 Tray of 25 Single-dose Plastic Fliptop Vials 0.9% (50 mL) NDC 0409-4888-12 Tray of 25 Single-dose LifeShield ® Plastic Fliptop Vials 0.9% (10 mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Instructions for Use of the Syringe Systems Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. LIFESHIELD ® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1097-3.0 Revised: 08/2021 Hospira logo

<table width="90%"><col width="65%"/><col width="35%"/><thead><tr><th align="left" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Unit of Sale</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Concentration</content></th></tr></thead><tbody><tr><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-1918-32</content> Tub of 50 Carpuject&#x2122;, Single-dose cartridge with Luer Lock for the Carpuject Syringe System</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>0.9% (2 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-1918-33</content> Tub of 25 Carpuject&#x2122;, Single-dose cartridge with Luer Lock for the Carpuject Syringe System</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (3 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-1918-35</content> Tub of 25 Carpuject&#x2122;, Single-dose cartridge with Luer Lock for the Carpuject Syringe System</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (5 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-4888-90</content> Tray of 10 Single-dose Plastic Fliptop Vials</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (10 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-4888-10</content> Tray of 25 Single-dose Plastic Fliptop Vials</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (10 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-4888-20</content> Tray of 25 Single-dose Plastic Fliptop Vials</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (20 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-4888-50</content> Tray of 25 Single-dose Plastic Fliptop Vials</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (50 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-4888-12</content> Tray of 25 Single-dose LifeShield^&#xAE; Plastic Fliptop Vials</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (10 mL)</paragraph></td></tr></tbody></table>

DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.6 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The plastic container is not made with PVC or DEHP. The plastic container is made of polypropylene formulated and developed for parenteral drugs. The suitability of the plastic container has been established through biological evaluations, which have shown the container passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests confirm the biological safety of the container closure system. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary.

INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/ hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre­-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.

sclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema. Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/ hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre­-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.

PRECAUTIONS Patients with Severe Renal Impairment Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see WARNINGS ). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions. Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Lithium Renal sodium and lithium clearance may be decreased during administration of 0.45% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations. Pregnancy There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman. Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION ). Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances.

result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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. Consider monitoring renal function in elderly patients.

Patients with Severe Renal Impairment Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see WARNINGS ). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Lithium Renal sodium and lithium clearance may be decreased during administration of 0.45% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Pregnancy There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman.

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION ). Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

Geriatric Use Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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. Consider monitoring renal function in elderly patients.

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during postapproval use of Sodium Chloride Injection, USP. 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. The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following: General disorders and administration site conditions : Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria Hypersensitivity reactions : Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders : Hypernatremia*, hyponatremia, hyperchloremic metabolic acidosis. Nervous System Disorders : Hyponatremic encephalopathy *Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE Excessive administration of: 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS . When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

DOSAGE AND ADMINISTRATION Important Administration Instructions Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. Use a dedicated line without any connections to avoid air embolism. Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

HOW SUPPLIED The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: NDC 0487-4301-05 - 50 mL, 64 units per shipper NDC 0487-4301-10 - 100 mL, 64 units per shipper NDC 0487-4301-25 - 250 mL, 35 units per shipper NDC 0487-4301-50 - 500 mL, 18 units per shipper Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C/ 77° F); brief exposure up to 40° C/ 104°F does not adversely affect the product.

DIRECTIONS FOR USE For Information on Risk of Air Embolism - see DOSAGE AND ADMINISTRATION . Inspection Before Preparation for Administration Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. Check solution for clarity and absence of foreign matter. If solution is not clear or contains foreign matter, discard the solution. Preparation for Administration Suspend container from eyelet support. Remove plastic protector from outlet port at bottom of container. Grip the small wing on the neck of the port with one hand. Grip the large wing on the cap with the other hand and twist. The cap will pop off. 3. Attach administration set. Refer to complete directions accompanying set. To Add Medication Additives may be incompatible. To add medication before solution administration Remove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward. Swab exposed additive port using aseptic technique. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To add medication during solution administration Close clamp on the set. Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in-use position and continue administration.

DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) and is hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia.

rhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. 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. The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following: General disorders and administration site condition s: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria Hypersensitivity reactions : Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders : Hypernatremia*, hyponatremia, hyperchloremic metabolic acidosis. Nervous System Disorders : Hyponatremic encephalopathy * Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE Excessive administration of: 0.45% Sodium Chloride Injection, USP can cause hyponatremia and hypernatremia. Both hypo- and hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death. 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS . When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

DOSAGE AND ADMINISTRATION Important Preparation and Administration Instructions Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear, and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. To reduce the risk of air embolism, adhere to the following preparation instructions for Lactated Ringer’s Injection, USP: Use a non-vented infusion set or close the vent on a vented set. Use a dedicated line without any connections (do not connect flexible containers in series). The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Sodium Chloride Injection, turn off the pump before the container is empty. Do not mix or administer 0.45% Sodium Chloride Injection, USP through the same administration set with whole blood or cellular blood components. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

HOW SUPPLIED The available size of each injection in VIAFLEX plastic containers are shown below: Size (mL) NDC 100 84549-049-48 Single pack Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

<table width="100%"><colgroup><col width="21%"/><col width="23%"/><col width="23%"/><col width="33%"/></colgroup><tbody><tr><td styleCode="Toprule " valign="top"><paragraph/></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">Size (mL)</content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph><content styleCode="bold">NDC</content></paragraph></td><td styleCode="Toprule " valign="top"><paragraph/></td></tr><tr><td valign="top"><paragraph/></td><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"/><td valign="top"><paragraph>100</paragraph></td><td valign="top"><paragraph>84549-049-48 </paragraph></td><td valign="top"/></tr><tr><td valign="top"><paragraph/></td><td valign="top"><paragraph>Single pack</paragraph></td><td valign="top"><paragraph/></td><td valign="top"/></tr><tr><td valign="top"><paragraph/></td><td valign="top"/><td valign="top"/><td valign="top"/></tr></tbody></table>

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION . To Open Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. Preparation for Administration Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set. To Add Medication Additives may be incompatible To add medication before solution administration Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To add medication during solution administration Close clamp on the set. Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in-use position and continue administration. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Baxter and Viaflex are trademarks of Baxter International Inc.

HEALTH CARE PROFESSIONAL LETTER Reporting Adverse Events or Product Quality Issues To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1- 800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax: • Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal ( https://productfeedback.baxter.com/ ). Please also refer to the local prescribing information of the imported product, translated into English, available for: • 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233 ) • 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235 ) • 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237 ) • 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238 ) Please refer to the FDA-approved prescribing information for each drug product listed below: • 0.9% Sodium Chloride Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178 ) • 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5 ) • 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5 ) • 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf ) DHCP Letter 1.jpg DHCP Letter 2.jpg DHCP Letter 3.jpg DHCP Letter 4.jpg DHCP Letter 5.jpg DHCP Letter 6.jpg DHCP Letter 7.jpg DHCP Letter 8.jpg DHCP Letter 9.jpg DHCP Letter 10.jpg DHCP Letter 11.jpg

<table width="100%"><col width="100.000%"/><tbody><tr><td align="left" valign="top" styleCode="Toprule Lrule Botrule Rrule"><content styleCode="bold">0.9% Sodium Chloride Injection, USP</content></td></tr></tbody></table>

DESCRIPTION 0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

CLINICAL PHARMACOLOGY When administered intravenously, the solution provides a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl-) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl-) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

General Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother. Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. Geriatric Use Clinical studies of Sodium Chloride Injection, USP 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 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 of concomitant disease or drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Teratogenic Effects Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing mother.

Pediatric Use The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

Geriatric Use Clinical studies of Sodium Chloride Injection, USP 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 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 of concomitant disease or drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).

INSTRUCTIONS FOR USE Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. Do not use if the solution is cloudy or a precipitate is present. To Add Medication Identify WHITE Additive Port with arrow pointing toward container. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. Mix container contents thoroughly. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of BLUE Infusion Port. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic container as follows: Product Code Unit of Sale Strength Each 6B1285 65219-432-85 Package of 20 0.9% (9 mg/mL) 65219-432-20 500 mL in a 500 mL free flex ® bag 6B1450 65219-328-50 Package of 10 0.9% (9 mg/mL) 65219-328-10 1,000 mL in a 1,000 mL free flex ® bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Manufactured for: Lake Zurich, IL 60047 Made in USA www.fresenius-kabi.com/us 451696B Revised: June 2023 Fresenius Kabi Logo

<table width="100%"><col width="22.750%" align="left"/><col width="22.400%" align="left"/><col width="24.425%" align="left"/><col width="30.425%" align="left"/><tbody><tr><td align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Product Code</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Unit of Sale</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Strength</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Each</content></td></tr><tr><td align="center" valign="middle" styleCode="Botrule Lrule Rrule">6B1285 </td><td align="center" valign="middle" styleCode="Botrule Rrule">65219-432-85 Package of 20 </td><td align="center" valign="middle" styleCode="Botrule Rrule">0.9% (9 mg/mL) </td><td align="center" valign="top" styleCode="Botrule Rrule">65219-432-20 500 mL in a 500 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td></tr><tr><td align="center" valign="middle" styleCode="Toprule Botrule Lrule Rrule">6B1450 </td><td align="center" valign="middle" styleCode="Toprule Botrule Rrule">65219-328-50 Package of 10 </td><td align="center" valign="middle" styleCode="Toprule Botrule Rrule">0.9% (9 mg/mL) </td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule">65219-328-10 1,000 mL in a 1,000 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td></tr></tbody></table>

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Unit of Sale Concentration NDC 84549-888-10 Single-dose Plastic Fliptop Vial 0.9% (10 mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Instructions for Use of the Syringe Systems Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. LIFESHIELD ® is the trademark of ICU Medical, Inc. and is used under license. Hospira logo

<table width="90%"><colgroup><col width="65%"/><col width="35%"/></colgroup><thead><tr><th align="left" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Unit of Sale</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Concentration</content></th></tr></thead><tbody><tr><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph/></td><td styleCode="Toprule Botrule " valign="top"/></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 84549-888-10</content> Single-dose Plastic Fliptop Vial </paragraph></td><td styleCode="Botrule " valign="top"><paragraph>0.9% (10 mL)</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph/></td><td styleCode="Botrule " valign="top"/></tr></tbody></table>

CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl‾) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na+) and chloride (Cl‾) are largely under the control of the kidney which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS & USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

HOW SUPPLIED 0.9% SODIUM CHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1464-1 0.9% SODIUM CHLORIDE INJECTION, USP 20mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 0.9% Sodium Chloride Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Instructions for Use of the Syringe Systems Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1097-2.0 10/2018 HOW SUPPLIED HS LOGO

DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

HOW SUPPLIED The available sizes of each injection in VIAFLEX plastic containers are shown below: Code Size (mL) NDC Product Name 2B1324 1000 NDC 85766-059-00 (relabeled from NDC 0338-0049-04) 0.9% Sodium Chloride Injection, USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

<table width="100%"><col width="21%"/><col width="23%"/><col width="23%"/><col width="33%"/><tbody><tr><td styleCode="Toprule" valign="top"><paragraph><content styleCode="bold">Code</content></paragraph></td><td styleCode="Toprule" valign="top"><paragraph><content styleCode="bold">Size (mL)</content></paragraph></td><td styleCode="Toprule" valign="top"><paragraph><content styleCode="bold">NDC</content></paragraph></td><td styleCode="Toprule" valign="top"><paragraph><content styleCode="bold">Product Name</content></paragraph></td></tr><tr><td styleCode="Botrule" valign="top"><paragraph>2B1324</paragraph></td><td styleCode="Botrule" valign="top"><paragraph>1000</paragraph></td><td styleCode="Botrule" valign="top"><paragraph>NDC 85766-059-00</paragraph><paragraph>(relabeled from NDC 0338-0049-04)</paragraph></td><td styleCode="Botrule" valign="top"> 0.9% Sodium Chloride Injection, USP</td></tr></tbody></table>

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION . To Open Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. Preparation for Administration Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set. To Add Medication Additives may be incompatible To add medication before solution administration Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To add medication during solution administration Close clamp on the set. Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in-use position and continue administration. Distributed by: Sportpharm LLC 379 Van Ness Ave 1401, Torrance, CA 90501 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501