Label: CALCIUM GLUCONATE 23%- 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 February 18, 2015

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS:

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

  • DOSAGE AND ADMINISTRATION:

    For intravenous administration only.
    Cattle                        250-500 mL
    Dosage may be repeated at 8 to 12 hour intervals if required.

  • CAUTION:

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

  • NOTE:

    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.

  • INFORMATION FOR OWNERS/CAREGIVERS

    RMS 92-545                     Iss. 04-11
    18-802-50

    Manufactured For
    VETTEK
    Blue Springs, MO 64014

    NET CONTENTS: 500 mL

    Lot No.          Exp.

  • GENERAL PRECAUTIONS

    STERILE

    For Animal Use Only

  • Each 100 mL CONTAINS:

    ACTIVE INGREDIENTS:
    Calcium Gluconate
         (provides 2.14 grams
         Calcium............................23 grams

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

  • INACTIVE INGREDIENTS:

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

    Electrolytes per 1000 mL:
    Calcium 1069 mEq;
    Hypertonic                    pH 2.5-4.5
    Osmolarity (calc.)
    6,782 mOsmol/L

  • STORAGE AND HANDLING

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

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    Container/Case Label 92-545

  • INGREDIENTS AND APPEARANCE
    CALCIUM GLUCONATE 23% 
    calcium gluconate injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:60270-852
    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
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4) 3.5 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60270-852-17500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/31/2013
    Labeler - VetTek (056387798)
    Registrant - VetTek (056387798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruibang Laboratories544807456api manufacture