Label: CALCIUM GLUCONATE injection, solution

  • Category: OTC ANIMAL DRUG LABEL

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 March 16, 2020

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  • INDICATIONS:

    For use as an aid in the treatment of hypocalcemia (parturient paresis, milk fever) in cattle.

  • DOSAGE AND ADMINISTRATION:

    Cattle: 250 to 500 mL

    Administer intravenously or intraperitoneally. Solution should be warmed to body temperature and administered slowly. This product is sterile in unopened container. It contains no preservative. Use entire contents when first opened. It should be handled under strict aseptic conditions. If there is no apparent improvement in the animal's condition within 24 hours, consult a veterinarian.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    NDC 11695-5411-5

    Calcium gluconate 23%

    Calcium borogluconate solution

    Volume: 16.907 fl oz (500 mL)

    Questions? (855) 724-3461

    Reorder #069167

    18-802

    RMS 92-1174

    AH-069167-01

    REV: 0719

    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

    Assembled in USA

  • Composition:

    Each 500 mL of sterile aqueous solution contains:

    Calcium............................................10.7 g

     (as calcium borogluconate, equivalent to calcium gluconate, 23%)

    Milliequivalents per liter

    Cations

       Calcium..................................1069 mEq/L 

    Anions

       Gluconate...............................1069 mEq/L

  • STORAGE AND HANDLING

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

  • GENERAL PRECAUTIONS

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    500 mL label500 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, INTRAPERITONEAL
    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)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture