Label: DEXTROSE injection, solution

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

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 December 27, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Dosage And Administration:

    Administer 50 mL per 100 lbs of body weight intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days as needed. 

  • Caution:

    This product should be warmed to body temperature and administered slowly. This product contains no preservative. 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 Monohydrate ..........................50 % w/v

  • Inactive Ingredients:

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

  • STORAGE AND HANDLING

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

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    NDC: 11695-1597-3

    18-801
    RMS 92-1024

    Volume: 16.907 (500 mL)

    Questions? (855) 724-3461

    Reorder #069168

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

    Distributed by:
    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Made in the USA

    AH-069168-L-02
    Rev: 0523

    Lot No.               Exp. Date

  • Indications:

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

  • PRINCIPAL DISPLAY PANEL

    Dextrose 500 mL
  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-1597
    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:11695-1597-3500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/21/2017
    Labeler - Covetrus (603750329)
    Registrant - Covetrus (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

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

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!