Label: DEXTROSE SOLUTION injection, solution

  • Category: OTC ANIMAL DRUG LABEL

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 August 4, 2016

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  • INDICATIONS:

    Dextrose 50% Solution is indicated for use as an
    aid in the treatment of uncomplicated primary
    ketosis in cattle.

  • DOSAGE AND ADMINISTRATION:

    The usual dose is 50 mL per 100 lbs of body
    weight. It should be administered intravenously
    only. Dosage may be repeated in 8 to 10 hours or
    on successive days if necessary.

  • CAUTION:

    It should be warmed to body temperature and
    administered slowly. This product contains no
    preservatives. Do not use if solution is not clear.
    Entire contents should be used upon opening.
    Discard any unused portion.

  • GENERAL PRECAUTIONS

    For Animal Use Only

    Keep Out of Reach of Children

  • INFORMATION FOR OWNERS/CAREGIVERS

    NET CONTENTS:
    500 mL (16.91 fl oz)

  • ACTIVE INGREDIENTS:

    Dextrose H2O............................50% w/v
    Water for Injection.............................q.s.

  • STORAGE AND HANDLING

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by:
    Aspen Veterinary Resources®, Ltd.
    Liberty, MO 64068 USA                           A151NT 03/16
    www.aspenveterinaryresources.com

    Manufactured by:
    Nova-Tech, Inc.
    Grand Island, NE 68801 USA                  18-801
                                                          RMS# 92-398

    Lot No.              Exp. Date

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    container label

  • INGREDIENTS AND APPEARANCE
    DEXTROSE SOLUTION 
    dextrose solution injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-801
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate250 g  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-801-50500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/10/2015
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976api manufacture, manufacture