Label: VITAL E NEWBORN- vitamin e, vitamin a, vitamin d injection, emulsion
- NDC Code(s): 59007-1061-0
- 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.
Updated October 8, 2015
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INDICATIONS & USAGE
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.
Calves (Dairy and Beef)
At Birth 3-5 mL
At Birth 1-2 mL
At birth 1/2 mL
At weaning 1 mL
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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)