VITAL E NEWBORN- vitamin e, vitamin a, vitamin 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.

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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

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.

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

®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

250 mL Bottle Label

VITAL E  NEWBORN
vitamin e, vitamin a, vitamin d injection, emulsion
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59007-1061
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-500 [iU]  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A50000 [iU]  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL50000 [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:59007-1061-0250 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)

Revised: 10/2015
Document Id: 83c48ccd-9323-43b8-a630-6b6b95bacec1
Set id: 015cbc09-20a2-4641-85fd-f08206ca0e38
Version: 1
Effective Time: 20151008
 
Stuart Products, Inc.