Label: DEXOLYTE SOLUTION- dexolyte injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 21, 2015

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

  • INDICATIONS:

    For use in conditions associated with
    fluid and electrolyte loss, such as dehydration,
    shock, vomiting and diarrhea, particularly when an
    immediate source of energy is also indicated.

  • CONTRAINDICATIONS:

    Do not administer intraperi-
    toneally to horses.

  • CAUTION:

    This product contains no preservatives.
    Use entire contents when first opened. Do not use if
    solution is not clear. Discard any unused solution.

  • DOSAGE AND ADMINISTRATION:

    Warm solution to
    body temperature and administer slowly (10 to 30
    mL per minute) by intravenous or intraperitoneal
    injection, using strict aseptic procedures.

    Adult Cattle and Horses - 1000 to 2000 mL
    Calves, Ponies and Foals - 500 to 1000 mLAdult Sheep and Swine - 500 to 1000 mL

    These are suggested dosages. The actual amount
    and rate of fluid administration must be judged by
    the veterinarian in relation to the condition being
    treated and the clinical response of the animal, being
    careful to avoid overhydration.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    RMS 92-1086                  Rev. 07-15
    18-804

    Lot No.      Exp. Date

    Manufactured by
    Nova-Tech, Inc.
    Grand Island, NE 68801

    Trademarks are property of
    Clipper Distributing Company, LLC

    Manufactured for:
    Clipper Distributing Company, LLC
    St. Joseph, MO 64507 

    Net Contents: 500 mL

    ELECTROLYTES - DEXTROSE

  • VETERINARY INDICATIONS

    FOR ANIMAL USE ONLY

  • WARNINGS AND PRECAUTIONS

    KEEP OUT OF REACH OF CHILDREN

  • Caution:

    Federal
    law restricts this
    drug to use by or
    on the order of a
    licensed veterinarian.

  • COMPOSITION:

    Each 500 mL of sterile aqueous
    solution contains:
    Dextrose . H2O.........................12.50 gSorbitol...................................12.50 gSodium Lactate.........................3.95 gSodium Chloride........................2.40 gPotassium Chloride....................0.37 gMagnesium Chloride . 6H2O.........0.21 gCalcium Chloride . 2H2O..............0.19 g

    Milliequivalents per liter

    CationsSodium...................................153 mEq/LPotassium..................................9 mEq/LCalcium.....................................6 mEq/LMagnesium................................4 mEq/LAnionsChloride..................................101 mEq/LLactate.....................................71 mEq/LOsmolarity (calc.) 602 mOsmol/L

  • STORAGE AND HANDLING

    Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    DEXOLYTE SOLUTION 
    dexolyte injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-617
    Route of AdministrationINTRAVENOUS, INTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate12.50 g  in 500 mL
    Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R) Sorbitol12.50   in 500 mL
    Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37) Sodium Lactate3.95   in 500 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride2.40   in 500 mL
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride0.37   in 500 mL
    Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride0.21   in 500 mL
    Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride0.19   in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-617-07500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2015
    Labeler - Clipper (150711039)
    Registrant - Clipper (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture