Animal NDC 13985-059-04 Vitamin E-300

Tocopherol

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-059-04
Proprietary Name Vitamin E-300 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 Tocopherol 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 Mwi/vetone
Product Type Otc Animal Drug
Usage Information
    Vitamin E-300 Injectable Tocopherol (natural-source vitamin E) is a clear, sterile, water emulsifiable solution of d-alpha-tocopherol for use as an aid in the prevention and treatment of vitamin E deficiencies in swine, cattle and sheep. This product is intended as a supplemental source of natural vitamin E.
Active Ingredient(s)
  • Alpha-tocopherol
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.

Vitamin E-300 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



Description



Vitamin E-300

Injectable d-alpha Tocopherol
Intramuscular or Subcutaneous Injection only

For animal use only.
Keep out of reach of children


Dosage & Administration



Dosage and Administration: Intramuscular or subcutaneous administration only. May be repeated as needed. If dose is greater than 5 mL, equally divide the dose and inject at two different sites.


Otc - Purpose



Natural tocopherols in feedstuffs can be destroyed through process, ensiling and storage. A reduced vitamin E intake can result in marginal deficiencies that may not be visible. Intramuscular or subcutaneous injections offer an efficient and rapid method to increase vitamin E status of animals.


Indications



Vitamin E-300 Injectable Tocopherol (natural-source vitamin E) is a clear, sterile, water emulsifiable solution of d-alpha-tocopherol for use as an aid in the prevention and treatment of vitamin E deficiencies in swine, cattle and sheep. This product is intended as a supplemental source of natural vitamin E.


Each Ml Contains:



Active Ingredient: 300 I.U. of vitamin E (as d-alpha-tocopherol, a natural source of vitamin E);

Inactive Ingredients: Compounded with 2% benzyl alcohol (preservative) in a water emulsifiable base.


Caution



Do not exceed recommended dosage. Occasionally, reactions of an anaphylactic or allergic nature may occur. Should such reactions occur, treat immediately with injection of epinephrine or antihistamines.


Warnings



Do not add water to solution.


Storage And Handling



Store between 15°–30°C (59°–86°F) in a dark place.

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