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 March 19, 2020

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  • INDICATIONS

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

  • DOSAGE & ADMINISTRATION

    For intravenous administration only.

    Cattle ........... 250-500 mL

    Dosage 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 USA

    18-802

    RMS 92-326

    NDC# 65207-802-50

    Nova-Tech® Animal Health

    Calcium Gluconate 23%

    Sterile Solution

    Net Contents:

    500 mL (16.91 fl oz)

    Assembled in USA

    Lot No. 

    Exp. Date

  • Each 500 mL Contains

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

     (provides 10.71 g of Calcium* per 500 mL)

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

    *Present as salts or boryl esters of gluconic acid.

  • 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

  • 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:65207-802
    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:65207-802-50500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/19/2020
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture