Label: VITAMIN B12- cyanocobalamin injection

  • NDC Code(s): 58005-400-04, 58005-400-05, 58005-400-06
  • Packager: Sparhawk Laboratories, Inc.
  • Category: PRESCRIPTION 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 26, 2011

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  • INDICATIONS

    For use as a supplemental nutritive source of vitamin B12 in cattle, horses, swine, sheep, dogs and cats.

  • DOSAGE AND ADMINISTRATION

    Inject subcutaneously or intramuscularly. May be injected intravenously at the discretion of the veterinarian.

    Cattle, Horses, Swine and Sheep--1 to 2 mL.
    Dogs and Cats--0.25 to 0.5 mL.

    Suggested dosage may be repeated at 1 to 2 week intervals, as indicated by condition and response.

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • COMPOSITION

    Each mL of sterile aqueous solution contains: 
    Cyanocobalamin (B12) 1000 mcg with sodium chloride 0.22% w/v, ammonium sulfate 0.1% w/v, citric acid 0.01% w/v, sodium citrate 0.008% w/v, and benzyl alcohol 1.0% v/v  (preservative).

  • STORAGE AND HANDLING


    Store at controlled room temperature between 15o to 30oC (59o - 86oF).

    Avoid exposure to light.

  • VITAMIN B12 INJECTION 1000 mcg/mL


    Vitamin B12 1000 mcg Label

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    Caution:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    NET CONTENTS

  • INGREDIENTS AND APPEARANCE
    VITAMIN B12  
    cyanocobalamin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58005-400
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58005-400-04100 mL in 1 VIAL
    2NDC:58005-400-05250 mL in 1 VIAL
    3NDC:58005-400-06500 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/11/1995
    Labeler - Sparhawk Laboratories, Inc. (147979082)