Animal NDC 59007-1061-0 Vital E Newborn

Vitamin E, Vitamin A, Vitamin D

Animal Product Information

Field Name Field Value
Animal NDC Code 59007-1061-0
Proprietary Name Vital E Newborn What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Vitamin E, Vitamin A, Vitamin D What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Stuart Products, Inc.
Product Type Otc Animal Drug
Usage Information
    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 mLLambs   At Birth                        1-2 mLPiglets   At birth                         1/2 mL   At weaning                     1 mL
Active Ingredient(s)
  • .alpha.-tocopherol, D-
  • Cholecalciferol
  • Vitamin A Palmitate
Inactive Ingredient(s)
  • ALCOHOL (3K9958V90M)
  • BENZYL ALCOHOL (LKG8494WBH)
  • ALCOHOL (3K9958V90M)
  • BENZYL ALCOHOL (LKG8494WBH)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Vital E Newborn Images

Vital E Newborn Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



®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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.