Label: VITAMIN A D- retinol cholecalciferol injection

  • NDC Code(s): 57561-332-04, 57561-332-05, 57561-332-06
  • Packager: Agri Laboratories, Ltd.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 31, 2017

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  • INDICATIONS & USAGE

    For Animal Use Only

    KEEP OUT OF REACH OF CHILDREN

    INDICATIONS

    For use as a supplemental nutritive source of vitamins A and D in cattle.

  • CAUTION

    Do not inject into meat animals within 60 days of marketing. 

    Administration of this product to well nourished animals may cause hypervitaminosis D which may result in hypercalcemia.  This condition may be harmful to the animal.

  • DOSAGE AND ADMINISTRATION

    Inject intramuscularly or subcutaneously preferably  in the neck area using aseptic technique.

    Calves- 1/2 to 1 mL,
    Yearling Cattle-1 to 2 mL
    Adult Cattle- 2 to 4 mL,

    These suggested dosage may be repeated after 60 days, if necessary.

  • COMPONENTS

    Each mL of sterile solution contains:

    ACTIVE INGREDIENTS

    Vitamin A  . . . . . . . . . 500,000 IU
    Vitamin D3  . . . . . . . . . 75,000 IU

    INACTIVE INGREDIENTS

    Emulsifiable base with vitamin E (antioxidant), N-methylpyrrolidone, polyoxyethylated (30) castor oil, propylene glycol dicaprylate, polyoxyethylene (20) sorbitan monooleate and benzyl alcohol 2%.

  • STORAGE AND HANDLING

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

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    AL Vit AD

  • INGREDIENTS AND APPEARANCE
    VITAMIN A D 
    retinol cholecalciferol injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57561-332
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RETINOL (UNII: G2SH0XKK91) (RETINOL - UNII:G2SH0XKK91) RETINOL500000 [iU]  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL75000 [iU]  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57561-332-04100 mL in 1 VIAL
    2NDC:57561-332-05250 mL in 1 VIAL
    3NDC:57561-332-06500 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/05/2001
    Labeler - Agri Laboratories, Ltd. (155594450)
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Safety

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Clinical Trials, PubMed, Biochemical Data Summary

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