Label: SODIUM CHLORIDE injection, solution

  • NDC Code(s): 0264-7800-00, 0264-7800-10, 0264-7800-20, 0264-7802-00, view more
    0264-7802-10
  • Packager: B. Braun Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 20, 2019

If you are a consumer or patient please visit this version.

  • 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.

  • 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.

  • CONTRAINDICATIONS

    These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental.

  • 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.

    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.

  • OVERDOSAGE

    In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Revised: January 2015
    EXCEL is a registered trademark of B. Braun Medical Inc.

  • 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

    1. Remove plastic protector from sterile set port at bottom of container.
    2. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    Warning: Some additives may be incompatible.

    To Add Medication Before Solution Administration

    1. Prepare medication site.
    2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
    3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

    To Add Medication During Solution Administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in use position and continue administration.
  • SPL UNCLASSIFIED SECTION

    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

  • PRINCIPAL DISPLAY PANEL - 0.9 g/1000 mL Container Label

    0.9% Sodium Chloride
    Injection USP

    REF L8000
    NDC 0264-7800-00
    DIN 01924303
    HK 22617

    1000 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.9 g;
    Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 5.6 (4.5-7.0); Calc. Osmolarity: 310 mOsmol/liter

    Electrolytes (mEq/liter): Na+ 154; Cl 154

    Sterile, nonpyrogenic. Single dose container. Do not use in
    series connection. For intravenous use only. Use only if
    solution is clear and container and seals are intact.

    WARNINGS: Some additives may be incompatible. Consult
    with pharmacist. When introducing additives, use aseptic
    techniques. Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid
    excessive heat. Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the
    overwrap, check for minute leaks by squeezing container firmly. If
    leaks are found, discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

     Other

    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

    Y94-003-229
    LD-195-3

    EXP
    LOT

    1000 mL Container Label L8000
  • PRINCIPAL DISPLAY PANEL - 0.9 g/500 mL Container Label

    0.9% Sodium Chloride
    Injection USP

    REF L8001
    NDC 0264-7800-10

    DIN 01924303
    HK 22617

    500 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.9 g;
    Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 5.6 (4.5–7.0); Calc. Osmolarity: 310 mOsmol/liter

    Electrolytes (mEq/liter): Na+ 154; Cl 154

    Sterile, nonpyrogenic. Single dose container. Do not use in series
    connection. For intravenous use only. Use only if solution is clear and
    container and seals are intact.

    WARNINGS: Some additives may be incompatible. Consult with
    pharmacist. When introducing additives, use aseptic techniques. Mix
    thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive heat.
    Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the overwrap, check for
    minute leaks by squeezing container firmly. If leaks are found, discard solution as
    sterility may be impaired. 

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

     Other

    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

    Y94-003-228
    LD-137-3

    EXP
    LOT

    500 mL Container Label L8001
  • PRINCIPAL DISPLAY PANEL - 0.9 g/250 mL Container Label

    0.9% Sodium Chloride
    Injection USP

    REF L8002
    NDC 0264-7800-20

    DIN 01924303
    HK 22617

    250 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.9 g;
    Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 5.6 (4.5–7.0); Calc. Osmolarity:310 mOsmol/liter

    Electrolytes (mEq/liter): Na+ 154;   Cl 154

    Sterile, nonpyrogenic. Single dose container. Do not use in series
    connection. For intravenous use only. Use only if solution is clear
    and container and seals are intact.

    WARNINGS: Some additives may be incompatible. Consult with
    pharmacist. When introducing additives, use aseptic techniques.
    Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive
    heat. Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the overwrap,
    check for minute leaks by squeezing container firmly. If leaks are found,
    discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP. 

    Rx only 

     Other

    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.
    Scarboough, Ontario M1H 2W4

    Y94-003-223
    LD-136-4

    EXP
    LOT

    250 mL Container Label L8002
  • PRINCIPAL DISPLAY PANEL - 0.45 g/1000 mL Container Label

    0.45% Sodium Chloride
    Injection USP

    REF L8020
    NDC 0264-7802-00
    DIN 01927949
    HK 22616

    1000 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.45 g;
    Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter,
    hypotonic

    Electrolytes (mEq/liter): Na+ 77; Cl 77

    Sterile, nonpyrogenic. Single dose container. Do not use in
    series connection. For intravenous use only. Use only if
    solution is clear and container and seals are intact.

    WARNINGS: Some additives may be incompatible.Consult
    with pharmacist. When introducing additives, use aseptic
    techniques. Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid
    excessive heat. Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the
    overwrap, check for minute leaks by squeezing container firmly. If
    leaks are found, discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

     Other

    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

    Y94-003-230  LD-135-3

    EXP
    LOT

    1000 mL Container Label L8020
  • PRINCIPAL DISPLAY PANEL - 0.45 g/500 mL Container Label

    0.45% Sodium Chloride
    Injection USP

    REF L8021
    NDC 0264-7802-10

    DIN 01927949
    HK 22616


    500 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.45 g;
    Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 5.6 (4.5-7.0); Calc. Osmolarity: 155 mOsmol/liter, hypotonic

    Electrolytes (mEq/liter): Na+ 77; Cl 77

    Sterile, nonpyrogenic. Single dose container. Do not use in series
    connection. For intravenous use only. Use only if solution is clear and
    container and seals are intact.

    WARNINGS: Some additives may be incompatible. Consult with
    pharmacist. When introducing additives, use aseptic techniques. Mix
    thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive heat.
    Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the overwrap, check for
    minute leaks by squeezing container firmly. If leaks are found, discard solution as
    sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP. 

    Rx only

     Other

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA USA 18018-3524
    1-800-227-2862
    www.bbraun.com

    In Canada, distributed by:
    B. Braun of Canada, Ltd.
    Scarborough, Ontario M1H 2W4

    Y94-003-227 
    LD-134-4

    EXP
    LOT

    500 mL Container Label L8021
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7800
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-7800-0012 in 1 CASE03/09/1988
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-7800-1024 in 1 CASE03/09/1988
    2500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:0264-7800-2024 in 1 CASE03/09/1988
    3250 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01963503/09/1988
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7802
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-7802-0012 in 1 CASE03/09/1988
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-7802-1024 in 1 CASE03/09/1988
    2500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01963503/09/1988
    Labeler - B. Braun Medical Inc. (002397347)