Vital E – 500: Product Information

VITAL E — 500- alpha-tocopherol, d- injection, emulsion
Stuart Products, Inc.

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.

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

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.

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

®VITAL-E is a registered trademark of

STUARTPRODUCTS, INC.

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

VITAL E — 500 vitamin e injection, emulsion

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59007-1032 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPHA-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) ALPHA-TOCOPHEROL, D- 500 [iU] in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL 180 in 1 mL BENZYL ALCOHOL 10 in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59007-1032-1 250 mL in 1 BOTTLE, GLASS None

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)

Revised: 10/2015 Stuart Products, Inc.