VITA-JEC ESSENTIAL E-300 (TOCOPHEROL) INJECTION [ASPEN VETERINARY RESOURCES, LTD]

VITA-JEC ESSENTIAL E-300 (TOCOPHEROL) INJECTION [ASPEN VETERINARY RESOURCES, LTD]
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NDC 46066-236-05
Set ID 94c252ab-f380-45d8-8e61-3f35d7c4c54b
Category OTC ANIMAL DRUG LABEL
Packager Aspen Veterinary Resources, Ltd
Generic Name
Product Class
Product Number
Application Number
  • PURPOSE

    Natural E-300

    (300 IU Vitamin E per mL)

    Injectable d-alpha-tocopherol

    Not For Use In Humans

    Keep Out of Reach of Children

    Natural tocopherols in feedstuffs can be destroyed through processing, ensiling and storage. A reduced vitamin E intake can result in marginal deficiencies that may not be visible. Intramuscular or subcutaneous injection offer an efficient and rapid method to increase vitamin E status of animals.

  • INDICATIONS

    Vita-Jec Essential E-300 Injectable d-alpha-tocopherol (natural-source vitamin E) is a clear, sterile, water emulsifiable solution of d-alpha-tocopherol for use as an aid in the prevention and treatment of vitamin E deficiencies in swine, cattle and sheep. This product is intended as a supplemental source of natural vitamin E. 

  • Each mL contains

    300 I.U. of vitamin E (as d-alpha-tocopherol, a natural source of vitamin E) compounded with 2% benzyl alcohol (preservative) in a water emulsifiable base. 

  • CAUTION

    Do not exceed recommended dosage. Occasionally, reactions of an anaphylactic or allergic nature may occur. Should such reactions occur, treat immediately with injection of epinephrine or antihistamines.

  • WARNING

    Do not add water to solution. 

  • STORAGE AND HANDLING

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

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • ADMINISTRATION AND DOSAGE

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

    SUGGESTED DOSAGE

    International

    mL   

    Units

    SWINE

       Sows and Gilts

          2 wks pre-partum

    4-6

                 1200-1800

          2 wks pre-breeding

    4-6

                 1200-1800

       Pigs

          At birth

    1-2

                    300-600

          At weaning

    2-3

                    600-900

    CATTLE (Dairy and Beef)

       Cows and Heifers

          2-3 wks pre -partum

    8-10

                 2400-3000

          At calving

    8-10

                 2400-3000

       Calves

          At birth

    4-6

                 1200-1800

          At weaning

    4-6

                 1200-1800

       Yearlings

    5-6

                 1500-1800

    SHEEP

       Ewes

          2-3 wks pre-partum

    4-5

                 1200-1500

          At lambing

    4-5

                 1200-1500

       Lambs

          At birth

    2-3

                    600-900

          At weaning

    2-3

                    600-900

       Finishing Lambs

    3-4

                  900-1200

  • PRINCIPAL DISPLAY PANEL

    AS Vit E

  • INGREDIENTS AND APPEARANCE
    VITA-JEC ESSENTIAL E-300 
    tocopherol injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-236
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL201 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-236-05250 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2010
    Labeler - Aspen Veterinary Resources, Ltd (627265361)
    Registrant - Sparhawk Laboratories, Inc. (147979082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082manufacture, analysis, api manufacture

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