Label: DEXTROSE- dextrose monohydrate injection

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

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Drug Label Information

Updated December 22, 2021

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  • INDICATIONS & USAGE

    INDICATIONS:

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

  • DOSAGE & ADMINISTRATION

    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.

  • DESCRIPTION

    COMPOSITION:

    Each 100 mL contains:

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

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

    May contain hydrochloric acid or sodium hydroxide for pH adjustment.

    2525 m0smol/liter (Calculated)

    Caloric Value per liter:  1700

    Hypertonic                       pH 3.5-6.5

  • STORAGE AND HANDLING

    STORAGE:

    STORE BETWEEN 15°C-30°C (59°F-86°F).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose monohydrate injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-0295
    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:61133-0295-5500 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/28/2016
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC Animal Health256232216manufacture
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

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