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 July 13, 2021

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  • GENERAL PRECAUTIONS

    FOR USE IN ANIMALS ONLY

  • EACH 100 mL CONTAINS: ACTIVE INGREDIENTS

    Calcium Gluconate
    (provides 2.14 grams Calcium) ...................23 grams

  • INACTIVE INGREDIENTS

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

    Boric acid
    (as a solubilizing agent) ......................... .3.5 grams

    Electrolytes per 1000 mL: Calcium.............1069 mEq

    Hypertonic                                              pH 2.5-4.5

  • INDICATIONS:

    To be used as an aid in the treatment of parturient paresis (milk fever) in cattle.

  • STORAGE AND HANDLING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • 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 aseptic conditions.  If there is no apparent improvement in the animal's condition within 24hours, consult a veterinarian.

  • GENERAL PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    ISS20XB09

    Manufactured for:
    DURVET, INC.
    Blue Springs, MO 64014
    www.durvet.com 

  • PRINCIPAL DISPLAY PANEL

    NDC 30798-126-17

    durvet

    Calcium Gluconate 23% SOLUTION

    Dura-Ster TS

    TERMINALLY STERILIZED

    NET CONTENTS: 500 mL (16.9 fl. oz.)

    image description

  • INGREDIENTS AND APPEARANCE
    CALCIUM GLUCONATE 
    calcium gluconate injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-126
    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:30798-126-17500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/07/2019
    Labeler - Durvet (056387798)
    Registrant - Durvet (056387798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Labotatorios Biogalenic851259507manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Calcium Private Limited862312449api manufacture