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 December 16, 2022

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  • CONTENTS

    Each 100 mL contains:

    ACTIVE INGREDIENTS

    Dextrose Monohydrate.............................50 g

    Water for Injection ...................................q.s.

    2525 mOsmol/liter (Calculated)

    Caloric Value per liter: 1700

    Hypertonic pH 3.2-6.5

  • STORAGE

    Store at controlled room temperature between 59 degrees and 86 degrees F (15 degree - 30 degree C).

  • VETERINARY INDICATIONS

    For animal use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS

    For use as an aid in the treatment of uncomplicated ketosis in cattle.

  • DOSAGE AND ADMINISTRATION

    Cattle: 100 to 500 mL depending on size and condition of animal. For intravenous use only. Solution should be warmed to body temperature and administered slowly.  This product is sterile in unopened container.  Contains no preservative. If entire contents are not used, discard unused portion. Handle under strict aseptic conditions.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Net contents: 500 mL (16.91 fl oz)

    RMS# 92-550

    18-801-50

  • PRINCIPAL DISPLAY PANEL

    image of container label
  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-067
    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:13985-067-00500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/16/2022
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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Safety

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