Label: VITAMIN E-AD-300- alpha tocopherol vitamin a vitamin d3 injection

  • NDC Code(s): 57561-413-05
  • Packager: Agri Laboratories, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 19, 2018

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  • DOSAGE & ADMINISTRATION

    INJECTABLE TOCOPHEROL WITH A+D

    (Vitamin A, D3 and E)

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    INTRAMUSCULAR OR SUBCUTANEOUS ONLY

    TAKE TIME OBSERVE LABEL DIRECTIONS

    ADMINISTRATION AND DOSAGE

    Intramuscular or subcutaneous administration only. If dose is greater than 5 mL, equally divide the dose and inject at two different sites.  May be repeated.

     SUGGESTED DOSAGE                           mL

     CATTLE (Diary and Beef)

                Cows and Heifers

                   2-3 wks pre-partum ..................... 6-10

                   At calving ................................... 8-10

                   End of lactation ........................... 8-10

                Calves

                   At birth ....................................... 4-6

                   At weaning .................................. 4-6

                   Yearlings ..................................... 5-6

  • CAUTION

    Anaphylactoid or allergic reactions, which have resulted in deaths, have been reported in individual animals as well as entire herds. Should such reactions or hypersensitivity occur, treat immediately with injection of epinephrine and/or antihistamines. Do not exceed recommended dosage. Administration of this product to well-nourished animals may cause hypervitaminosis D, which may result in hypercalcemia and hyperphosphatemia.

  • WARNING

    Do not add water to solution. Not for human use. Keep out of reach of children. 

  • STORAGE AND HANDLING

    Store between 15° and 30°C (59°-86°F) in a dark place.

  • Each mL contains:

    Active Ingredients: 300 I.U. of vitamin E (as d-alpha-tocopherol, a natural source of vitamin E); 100,000 I.U. Vitamin A Propionate. 10,000 I.U. vitamin D3 Inactive Ingredients: 2% benzyl alcohol (preservative) in a water emulsifiable base.

  • INDICATIONS

    Vitamin E-AD-300 is a clear, sterile, non-aqueous solution of vitamin A, vitamin D3 and vitamin E. The product is intended as a supplemental source of vitamins A, D, and E.

    Natural vitamin A (carotenes), and tocopherols can be destroyed in feedstuffs through processing, ensiling and storage. Due to these losses, reduced intakes of fat-soluble vitamins can occur in animals maintained in continual confinement compared to animals allowed to graze lush pasture. Intramuscular or subcutaneous injections offer an efficient and rapid method to increase vitamin A, vitamin D and vitamin E status of animals.

  • PRINCIPAL DISPLAY PANEL

    AL Vit EAD

  • INGREDIENTS AND APPEARANCE
    VITAMIN E-AD-300 
    alpha tocopherol vitamin a vitamin d3 injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57561-413
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-201 mg  in 1 mL
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A3.6 mg  in 1 mL
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D2.5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57561-413-05250 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2008
    Labeler - Agri Laboratories, Inc. (155594450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082manufacture, api manufacture, analysis