Label: DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate and sodium chloride injection, solution

  • NDC Code(s): 0338-0073-03, 0338-0073-04, 0338-0077-02, 0338-0077-03, view more
    0338-0077-04, 0338-0081-02, 0338-0081-03, 0338-0081-04, 0338-0085-02, 0338-0085-03, 0338-0085-04, 0338-0089-02, 0338-0089-03, 0338-0089-04, 0338-0095-03, 0338-0095-04
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 12/12

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

  • DESCRIPTION

    Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

    Table 1
    *
    Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.
    Size (mL) Composition (g/L) *Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L)
    **Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Chloride
    2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 1000 25 4.5 280 4.5
    (3.2 to 6.5)
    77 77 85
    5% Dextrose and 0.2% Sodium Chloride Injection, USP 250 500 1000 50 2 321 4.0
    (3.2 to 6.5)
    34 34 170
    5% Dextrose and 0.33% Sodium Chloride Injection, USP 250 500 1000 50 3.3 365 4.0
    (3.2 to 6.5)
    56 56 170
    5% Dextrose and 0.45% Sodium Chloride Injection, USP 250 500 1000 50 4.5 406 4.0
    (3.2 to 6.5)
    77 77 170
    5% Dextrose and 0.9% Sodium Chloride Injection, USP 250 500 1000 50 9 560 4.0
    (3.2 to 6.5)
    154 154 170
    10% Dextrose and 0.9% Sodium Chloride Injection, USP 500 1000 100 9 813 4.0
    (3.2 to 6.5)
    154 154 340
    Chemical Structure

    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.

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  • CLINICAL PHARMACOLOGY

    Dextrose and Sodium Chloride Injection, USP has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

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  • INDICATIONS AND USAGE

    Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes, and calories.

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  • CONTRAINDICATIONS

    Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

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  • WARNINGS

    Dextrose and 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.

    Dextrose injections with low electrolyte concentrations should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood.

    The intravenous administration of Dextrose and 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 dilutional states is inversely proportional to the electrolyte concentrations 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.

    Excessive administration of Dextrose and Sodium Chloride Injection, USP may result in significant hypokalemia.

    In patients with diminished renal function, administration of Dextrose and Sodium Chloride Injection, USP may result in sodium retention.

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  • PRECAUTIONS

    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.

    Dextrose and Sodium Chloride Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

    Administration of hypertonic solutions may cause venous irritation, including phlebitis. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states. See Table 1 in the DESCRIPTION section for the osmolarities of the Dextrose and Sodium Chloride Injection, USP solutions.

    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 Dextrose and Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with Dextrose and Sodium Chloride Injection, 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 Dextrose and Sodium Chloride Injection, USP. It is also not known whether Dextrose and Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injection, 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 Dextrose and Sodium Chloride Injection, USP is administered to a nursing mother.

    Pediatric Use

    The use of Dextrose and Sodium Chloride Injection, USP in pediatric patients is based on clinical practice.

    Newborns – especially those born premature and with low birth weight – are at increased risk of developing hypo– or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

    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 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 (applies to solutions containing less than 0.9% sodium chloride).

    Geriatric Use

    Clinical studies of Dextrose and 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 the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Do not administer unless solution is clear and seal is intact.

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  • ADVERSE REACTIONS

    - Hypersensitivity reactions, including anaphylaxis and chills

    - Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride)

    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.

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  • DOSAGE AND ADMINISTRATION

    As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

    The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

    Additives may be incompatible. Complete information is not available.

    Those additives known to be incompatible should not be used. Consult with 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. Do not store solutions containing additives.

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  • HOW SUPPLIED

    Dextrose and Sodium Chloride Injection, USP in VIAFLEX plastic container is supplied as follows:

    Code Size (mL) NDC Product Name
    2B1023 500 0338-0073-03 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP
    2B1024 1000 0338-0073-04
    2B1092 250 0338-0077-02 5% Dextrose and 0.2% Sodium Chloride Injection, USP
    2B1093 500 0338-0077-03
    2B1094 1000 0338-0077-04
    2B1082 250 0338-0081-02 5% Dextrose and 0.33% Sodium Chloride Injection, USP
    2B1083 500 0338-0081-03
    2B1084 1000 0338-0081-04
    2B1072 250 0338-0085-02 5% Dextrose and 0.45% Sodium Chloride Injection, USP
    2B1073 500 0338-0085-03
    2B1074 1000 0338-0085-04
    2B1062 250 0338-0089-02 5% Dextrose and 0.9% Sodium Chloride Injection, USP
    2B1063 500 0338-0089-03
    2B1064 1000 0338-0089-04
    2B1163 500 0338-0095-03 10% Dextrose and 0.9% Sodium Chloride Injection, USP
    2B1164 1000 0338-0095-04

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

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  • DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

    To Open

    Tear overwrap down side at slit and remove solution container. 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

    1. Suspend container from eyelet support.
    2. Remove protector from outlet port at bottom of container.
    3. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    WARNING

    Additives may be incompatible.

    To add medication before solution administration

    1. Prepare medication site.
    2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    3. 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

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by 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.

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA

    *For Bar Code Position Only
    071970015

    07-19-70-015  Rev.  September 2013

    BAXTER, VIAFLEX and PL 146 are trademarks of
    Baxter International Inc.

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  • PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

     

    Dextrose and Sodium Chloride Representative Container Label 0338-0089-02

    Container Label

    LOT EXP

    2B1062
    NDC 0338-0089-02

    5% Dextrose and
    0.9% Sodium Chloride
    Injection USP

    250 mL EACH 100 mL CONTAINS
    5 g DEXTROSE HYDROUS
    USP 900 mg SODIUM CHLORIDE USP
    pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 154
    CHLORIDE 154 HYPERTONIC OSMOLARITY
    560 mOsmol/L (CALC) STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER
    ADDITIVES MAY BE INCOMPATIBLE CONSULT
    WITH PHARMACIST IF AVAILABLE WHEN
    INTRODUCING ADDITIVES USE ASEPTIC
    TECHNIQUE MIX THOROUGHLY DO NOT
    STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS
    CAUTIONS SQUEEZE AND INSPECT INNER
    BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND MUST NOT
    BE USED IN SERIES CONNECTIONS DO NOT
    USE UNLESS SOLUTION IS CLEAR RX ONLY
    STORE UNIT IN MOISTURE BARRIER
    OVERWRAP AT ROOM TEMPERATURE
    (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    VIAFLEX CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER Logo

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN USA

    FOR PRODUCT INFORMATION 1-800-933-0303

    50

    100

    150

    200

    07-25-31-365

    Dextrose and Sodium Chloride Representative Carton Label 0338-0089-02

    Carton Label

    2B1063Q 36-500 ML

    VIAFLEX® CONTAINER

    5% DEXTROSE AND
    0.9% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380089029

    Dextrose and Sodium Chloride Representative Container Label 0338-0073-03

    2B1023
    NDC 0338-0073-03
    DIN 00060720

    2.5% Dextrose and
    0.9% Sodium Chloride
    Injection USP

    500 mL

    EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP 450
    mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L
    SODIUM 77 CHLORIDE 77 HYPERTONIC OSMOLARITY 280 mOsmol/L
    (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER
    ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF
    AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC
    TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE
    INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS
    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS
    PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT
    BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION
    IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP
    AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    Baxter Logo

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    DISTRIBUTED IN CANADA BY
    BAXTER CORPORATION
    TORONTO ONTARIO CANADA

    VIAFLEX CONTAINER
    PL 146 PLASTIC

    FOR PRODUCT INFORMATION
    1-800-933-0303

    BAXTER VIAFLEX AND
    PL 146 ARE TRADEMARKS OF
    BAXTER INTERNATIONAL INC

    07-25-38-743

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    Dextrose and Sodium Chloride Representative Carton Label  0338-0073-03

    Carton Label

    2B1023Q 24-500 ML

    VIAFLEX® CONTAINER

    2.5% DEXTROSE AND
    0.45% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) XXXXX (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380073035

    Dextrose and Sodium Chloride Representative Container Label 0338-00077-02

    Container Label

    LOT EXP

    2B1062
    NDC 0338-0089-02

    5% Dextrose and
    0.9% Sodium Chloride
    Injection USP

    250 mL EACH 100 mL CONTAINS
    5 g DEXTROSE HYDROUS
    USP 900 mg SODIUM CHLORIDE USP
    pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 154
    CHLORIDE 154 HYPERTONIC OSMOLARITY
    560 mOsmol/L (CALC) STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER
    ADDITIVES MAY BE INCOMPATIBLE CONSULT
    WITH PHARMACIST IF AVAILABLE WHEN
    INTRODUCING ADDITIVES USE ASEPTIC
    TECHNIQUE MIX THOROUGHLY DO NOT
    STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS
    CAUTIONS SQUEEZE AND INSPECT INNER
    BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND MUST NOT
    BE USED IN SERIES CONNECTIONS DO NOT
    USE UNLESS SOLUTION IS CLEAR RX ONLY
    STORE UNIT IN MOISTURE BARRIER
    OVERWRAP AT ROOM TEMPERATURE
    (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    VIAFLEX CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER Logo

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN USA

    FOR PRODUCT INFORMATION 1-800-933-0303

    50

    100

    150

    200

    07-25-31-365

    Dextrose and Sodium Chloride Representative Carton Label 0338-0077-02

    Carton Label

    2B1092Q 36-250 ML

    VIAFLEX® CONTAINER

    5% DEXTROSE AND
    0.2% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380077026

    Dextrose and Sodium Chloride Representative Container Label 0338-0081-03

    Container Label

    LOT EXP

    2B1083
    NDC 0338-0081-03

    5% Dextrose and
    0.33% Sodium Chloride
    Injection USP

    500 mL

    EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
    330 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5)
    mEq/L SODIUM 56 CHLORIDE 56 OSMOLARITY 356
    mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE
    CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH
    PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE
    ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE
    DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE
    DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE
    FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT
    USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN
    MOISTURE BARRIER OVERWRAP T ROOM TEMPERATURE
    (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT
    SEE INSERT

    VIAFLEX CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
    BAXTER INTERNATIONAL INC

     FOR PRODUCT INFORMATION 1-800-933-0303

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    07-25-34-096

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    Dextrose and Sodium Chloride Representative Carton Label 0338-0081-03

    2B1083Q 24-500 ML

    VIAFLEX® CONTAINER

    5% DEXTROSE AND
    0.33% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) XXXXX (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380081030

    Dextrose and Sodium Chloride Representative Container Label 0338-0085-02

    Container Label

    LOT EXP

    2B1072
    NDC 0338-0085-02

    5% Dextrose and
    0.45% Sodium Chloride
    Injection USP

    250 mL EACH 100 mL CONTAINS
    5 g DEXTROSE HYDROUS
    USP 450 mg SODIUM CHLORIDE USP
    pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 77
    CHLORIDE 77 HYPERTONIC OSMOLARITY
    406 mOsmol/L (CALC) STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER
    ADDITIVES MAY BE INCOMPATIBLE CONSULT
    WITH PHARMACIST IF AVAILABLE WHEN
    INTRODUCING ADDITIVES USE ASEPTIC
    TECHNIQUE MIX THOROUGHLY DO NOT
    STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS
    CAUTIONS SQUEEZE AND INSPECT INNER
    BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND MUST NOT BE
    USED IN SERIES CONNECTIONS DO NOT USE
    UNLESS SOLUTION IS CLEAR RX ONLY
    STORE UNIT IN MOISTURE BARRIER
    OVERWRAP AT ROOM TEMPERATURE
    (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    VIAFLEX CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE
    TRADEMARKS OF BAXTER INTERNATIONAL INC

    FOR PRODUCT INFORMATION
    1-800-933-0303

    BAXTER Logo

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN USA

    50

    100

    150

    200

    07-25-31-441

    Dextrose and Sodium Chloride Representative Carton Label 0338-085-02

    Carton Label

    2B1072Q 36-250 ML

    VIAFLEX® CONTAINER

    5% DEXTROSE AND
    0.45% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380085021

    Dextrose and Sodium Chloride Representative Container Label 0338-0095-04

    LOT EXP

    2B1164
    NDC 0338-0095-04

    10% Dextrose and
    0.9% Sodium Chloride
    Injection USP

    1000 mL

    EACH 100 mL CONTAINS 10 g DEXTROSE HYDROUS USP 900
    mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L
    SODIUM 154 CHLORIDE 154 OSMOLARITY 813 mOsmol/L
    (CALC) HYPERTONIC MAY CAUSE VEIN DAMAGE STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
    INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
    THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE
    AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY
    DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES
    CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR
    FEDERAL (USA) LAW PROHIBITS DISPENSING WITHOUT
    PRESCRIPTION STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    Viaflex® CONTAINER
    PL 146® PLASTIC

     FOR PRODUCT INFORMATION
    CALL 1-800-933-0303

    07-25-02-859

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    Dextrose and Sodium Chloride Representative Carton Label 0338-0095-04

    Carton Label

    2B1164 12-1000 ML

    VIAFLEX CONTAINER

    10% DEXTROSE AND
    0.9% SODIUM CHLORIDE INJ, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380095044

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  • INGREDIENTS AND APPEARANCE
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0073
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 450 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0073-03 500 mL in 1 BAG
    2 NDC:0338-0073-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016697 03/22/1971
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0077
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 200 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0077-02 250 mL in 1 BAG
    2 NDC:0338-0077-03 500 mL in 1 BAG
    3 NDC:0338-0077-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016689 12/08/1970
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0081
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 330 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0081-02 250 mL in 1 BAG
    2 NDC:0338-0081-03 500 mL in 1 BAG
    3 NDC:0338-0081-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016687 03/22/1971
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0085
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 450 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0085-02 250 mL in 1 BAG
    2 NDC:0338-0085-03 500 mL in 1 BAG
    3 NDC:0338-0085-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016683 03/22/1971
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0089
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0089-02 250 mL in 1 BAG
    2 NDC:0338-0089-03 500 mL in 1 BAG
    3 NDC:0338-0089-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016678 12/09/1970
    DEXTROSE AND SODIUM CHLORIDE 
    dextrose and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0095
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 10 g  in 100 mL
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0095-03 500 mL in 1 BAG
    2 NDC:0338-0095-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016696 03/22/1971
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 059140764 MANUFACTURE(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), ANALYSIS(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), LABEL(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), PACK(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095), STERILIZE(0338-0073, 0338-0077, 0338-0081, 0338-0085, 0338-0089, 0338-0095)
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