Label: VITAL E - REPRO- vitamin e, vitamin a, vitamin d injection, emulsion

  • 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 October 14, 2015

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    INDICATIONS:

    VITAL E–Repro is a clear, sterile, non-aqueous solution of vitamins E, A, and D for use as a supplemental source of those fat-soluble vitamins in cattle, sheep, and swine. Each mL provides vitamin E in its highest biologically-available form - d-alpha-tocopherol, the same form found in colostrum and milk.

    Intramuscular or subcutaneous injections of VITAL E-Repro offer an efficient and rapid method to increase status of the fat-soluble vitamins E, A, and D in animals.

    ADMINISTRATION AND DOSAGE:

    Intramuscular or Subcutaneous Administration Only.

    SUGGESTED DOSAGE:

    CATTLE (Dairy and Beef)

       Cows and Heifers

          2 weeks pre-partum                        8-10 mL

    SHEEP

       Ewes

          2 weeks pre-partum                        3-4 mL

    SWINE

       Gilts

          2 weeks pre-breeding                      4-5 mL

          2 weeks pre-partum                        4-5 mL

       Sows

          2 weeks pre-partum                         5-6 mL

          At weaning                                      5-6 mL

  • PRECAUTIONS

    CAUTION: Anaphylactoid or allergic reactions, which may result in deaths, may occur in individual animals. Should such reactions or hypersensitivity occur,  treat immediately with injection of epinephrine and/or antihistamines.

    Do Not Exceed Recommended Dosage.

  • STORAGE AND HANDLING

    IMPORTANT: Stored between 40° to 78° F (4°-26°C). Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    ®VITAL-E is a registered trademark of

    STUART PRODUCTS, INC.

    Manufactured in Mexico for

    STUART PRODUCTS, INC.

    112 Bedford Road

    Bedford, Texas 76022

  • Principal Display Panel - 250 mL Bottle

    STUART PRODUCTS INC

    VITAL E® - Repro

    Vitamin E, A and D Injection

    NOT FOR HUMAN USE

    KEEP OUT OF REACH OF CHILDREN

    Each ml contains: 300 I.U. vitamin E (as d-alpha-tocopherol, a natural-source of vitamin E), 200,000 I.U. Vitamin A (as retinyl-palmitate), and 100,000 I.U. Vitamin D (as cholecalciferl) compounded with 18% ethyl alcohol and 1% benzyl alcohol (preservative) in an emulsifiable base.

    NET CONTENTS: 250 mL

    250 mL bottle label

  • INGREDIENTS AND APPEARANCE
    VITAL E -  REPRO
    vitamin e, vitamin a, vitamin d injection, emulsion
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59007-1051
    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-300 [iU]  in 1 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A200000 [iU]  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL100000 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 180   in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 10   in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59007-1051-0250 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2015
    Labeler - Stuart Products, Inc. (602508723)