Label: DEXTROSE injection, solution

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

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Drug Label Information

Updated August 14, 2017

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  • DOSAGE AND ADMINISTRATION:

    For
    intravenous administration only.

  • CAUTION:

    Intravenous administration
    must be done slowly and made under strict
    aseptic conditions. Solution should be
    warmed to body temperature prior to
    administration. Cattle: 100 to 500 mL de-
    pending on size and condition. Treatment
    may be repeated in several hours or on
    successive days as needed.

    This is a single dose container. This pro-
    duct contains no preservative. After a
    quantity has been withdrawn for injection,
    the remainder should be discarded. Do not
    administer intraperitoneally.

  • GENERAL PRECAUTIONS

    FOR ANIMAL USE ONLY
    KEEP OUT OF REACH OF CHILDREN

  • Each 100 mL contains:

    Dextrose • H2O..............50 gms.

  • STORAGE AND HANDLING

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

  • INDICATIONS:

    For use as an aid in
    the treatment of acetonemia
    (Ketosis) in cattle.

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    RMS 92-540

    18-801-50

    Iss. 08-08

    Lot No.

    Exp. Date

    Net Contents:
    500 mL

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

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

  • PRINCIPAL DISPLAY PANEL

    500 product label

  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-543
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE50 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-543-07500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/14/2017
    Labeler - Clipper (150711039)
    Registrant - Clipper (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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