Label: CALCIUM GLUCONATE 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 April 5, 2024

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  • INDICATIONS:

    For use in cattle as an aid in treating uncomplicated milk fever (parturient paresi).

  • DOSAGE AND ADMINISTRATION:

    Administer to cattle 200-500 mL intravenously. Dosage may be repeated in 8 to 12 hour intervals as needed. Monitor animal's condition closely. Re-treatment may be necessary. If there is no noticeable improvement within 24 hours following treatment, consult your veterinarian. Aseptic precautions should be observed.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    NDC 11695-6411-5

    Calcium gluconate 23%

    Sterile Solution

    Net Contents: 16.91 fl oz (500 mL)

    Questions? (855) 724-3461

    Reorder #069167

    18-802

    RMS 92-1174

    Made in the USA

    AH-069167-L-02

    REV: 0523

    Lot No.

    Exp. Date

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801

  • Composition:

    Each 500 mL contains:

    Active ingredients:

    Calcium Gluconate ............................................ 23% w/v

       (provides 10.71 g of Calcium* per 500 mL) 

       * Present as salts or boryl esters of gluconic acid.

    Inactive ingredients:

    Water for injection .................................. q.s.

       Contains boric acid as a solubilizing agent.

  • STORAGE AND HANDLING

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

  • GENERAL PRECAUTIONS

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • Caution:

    Solution should be warmed to body temperature and administered slowly. Entire contents should be used upon opening, as this product contains no preservatives. Discard any unused portion. Do not use if solution is cloudy or contains precipitate.

  • PRINCIPAL DISPLAY PANEL

    500 mL label

  • INGREDIENTS AND APPEARANCE
    CALCIUM GLUCONATE 
    calcium gluconate injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6411
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM GLUCONATE23 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-6411-5500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/16/2020
    Labeler - Covetrus (603750329)