Label: DEXTROSE 50% SOLUTION- dextrose injection, solution

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

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Drug Label Information

Updated March 13, 2020

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  • 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 presevatives. 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

  • Active Ingredients

    Dextrose H2O...........................50% w/v

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

  • Indications:

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

  • STORAGE AND HANDLING

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

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801 USA

    18-801

    RMS 92-325

    NDC# 65207-801-50

    Nova-Tech® Animal Health

    Dextrose 50% Solution

    Sterile Solution

    Net Contents:

    500 mL (16.91 fl oz)

    Assembled in USA

    Lot No.               Exp. Date

  • PRINCIPAL DISPLAY PANEL

    Container labelContainer label

  • INGREDIENTS AND APPEARANCE
    DEXTROSE 50% SOLUTION 
    dextrose injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:65207-801
    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:65207-801-50500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/13/2020
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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