Label: VITAL E - 500- vitamin e injection, emulsion
- NDC Code(s): 59007-1032-1
- Packager: Stuart Products, Inc.
- 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.
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INDICATIONS & USAGE
INDICATIONS:
VITAL E–500 is a clear, sterile, non-aqueous solution of Vitamin E for use as a supplemental source of natural-source vitamin E in cattle, sheep, and swine. Each mL provides 500 I.U. vitamin E in it's highest biologically-available form - d-alpha-tocopherol; in a proven delivery system.
Natural tocopherols can be destroyed in feedstuffs through processing, ensiling, and storage. A reduced vitamin E intake can result in marginal deficiencies that may not be visible.
Intramuscular or subcutaneous injections of VITAL E-500 offer an efficient and rapid method to increase vitamin E status of animals.
ADMINISTRATION AND DOSAGE:
Intramuscular or Subcutaneous Adminstration Only. May be repeated. If dose is greater than 5 mL, equally divide dose and inject at two different sites.
SUGGESTED DOSAGE:
CATTLE (Dairy and Beef)
Cows and Heifers 5-6 mL
Calves
At Birth 2-3 mL
At Weaning 3-4 mL
Yearlings 4-5 mL
SHEEP
Ewes 2-3 mL
Lambs
At Birth: .5-1 mL
At Weaning 1-2 mL
SWINE
Sows and Gilts
2 wks pre-partum 3-4 mL
2 wks pre-breeding 3-4 mL
Pigs
At births .25-.50 mL
Weaning: 1-2 mL
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PRECAUTIONS
CAUTION: Anaphylactoid or allergic reactions, which may result in deaths, abortion, and/or premature births, may occur 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.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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Principal Display Panel - 250 mL Bottle
STUART PRODUCTS INC
VITAL E® - 500
Vitamin E Injection
(500 I.U. Vitamin E per mL)
NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
Each ml contains: 500 International Units of Vitamin E (as d-alpha-tocopherol, a natural-source of Vitamin E) compounded with 18% ethyl alcohol and 1% benzyl alcohol (preservative) in an emulsifiable base.
NET CONTENTS: 250 mL
Manufactured in Mexico for
STUART PRODUCTS, INC.
112 Bedford Road
Bedford, Texas 76022
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INGREDIENTS AND APPEARANCE
VITAL E - 500
vitamin e injection, emulsionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59007-1032 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) ALPHA-TOCOPHEROL, D- 500 [iU] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 180 in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 10 in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59007-1032-1 250 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2015 Labeler - Stuart Products, Inc. (602508723)