VITAL E NEWBORN- vitamin e, vitamin a, vitamin d injection, emulsion

Vital E by

Drug Labeling and Warnings

Vital E by is a Animal medication manufactured, distributed, or labeled by Stuart Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS:

VITAL E–Newborn is a clear, sterile, non-aqueous solution of vitamins E, A and D for use as a supplemental source of vitamin E, vitamin A and vitamin D in newborn calves, lambs and piglets. Each mL provides Vitamin E in its highest biologically-available form d-alpha tocopherol, the same form found in colostrum and milk.

Newborns are born deficient in fat-soluble vitamins and depend on colostrum and milk to provide adequate amounts. A reduced intake of these critically important vitamins can result in marginal deficiencies that may not be visible.

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

ADMINISTRATION AND DOSAGE:

Intramuscular or Subcutaneous Adminstration Only.

SUGGESTED DOSAGE:

Calves (Dairy and Beef)

   At Birth                        3-5 mL

Lambs

   At Birth                        1-2 mL

Piglets

   At birth                         1/2 mL

   At weaning                     1 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 form freezing.

SPL UNCLASSIFIED SECTION

®VITAL-E is a registered trademark of

STUART PRODUCTS, INC.

Principal Display Panel - 250 mL Bottle

STUART PRODUCTS INC

VITAL E® - Newborn

Vitamin Injection for Neonates

(Vitamin E, Vitamin A, and vitamin D)

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), 50,000 I.U. vitamin A (as retinyl-palmitate) and 50,000 I.U. vitamin D (as cholecalciferol) 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

INGREDIENTS AND APPEARANCE

VITAL E  NEWBORN
vitamin e, vitamin a, vitamin d injection, emulsion

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 59007-1061
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
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	50000 [iU]  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	50000 [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: 59007-1061-0	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)