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 November 26, 2019

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  • INDICATIONS:

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

  • DOSAGE AND ADMINISTRATION:

    For intravenous administrion only.

    Cattle: 250 to 500 mL

    Doasage may be repeated at 8 to 12 hour intervals if required.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by

    Nova-Tech Inc.

    Grand Island, NE 68801

    RMS 92-593

    18-802-50

    Iss. 10-19

    Lot No.

    Exp. Date

    NDC 57319-630-07

    Calcium Gluconate 23%

    Sterile - Preservative Free

    Next Contents: 500 mL

    PhoenixTM

    Manufactured for:

    Clipper Distributing Company, LLC 

    St. Joseph, MO 64507

    Trademarks are property

    of Clipper Distributing

    Company, LLC

  • ACTIVE INGREDIENT

    Each 500 mL CONTAINS:

    Active Ingredients

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

     (provides 10.71 g of Calcium * per 500 mL)

    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 

  • STORAGE AND HANDLING

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

  • GENERAL PRECAUTIONS

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • Caution:

    Solution should be warmed to body temperature and admisinstered slowly. Entire contents should be used upon entering, as this product contains no preservative. Discard any unused portion. Do no 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.

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    CALCIUM GLUCONATE 
    calcium gluconate injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-630
    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:57319-630-07500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/04/2019
    Labeler - Phoenix (150711039)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture