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
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Drug Label Information
Updated October 8, 2015
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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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
VITAL E NEWBORN
vitamin e, vitamin a, vitamin d injection, emulsionProduct 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)