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Animal NDC 57561-412-05 Vitamin E-300

Tocopherol

Animal Product Information

Field Name Field Value
Animal NDC Code 57561-412-05
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 Agri Laboratories, Ltd.
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 Images

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



Dosage & Administration



INJECTABLE TOCOPHEROL

(300 IU vitamin E per mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INTRAMUSCULAR OR SUBCUTANEOUS ONLY

ADMINISTRATION AND DOSAGE

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

SUGGESTED DOSAGE

International

mL

Units

SWINE

   Sows and Gilts

      2 wks pre-partum

4-6

             1200-1800

      2 wks pre-breeding

4-6

             1200-1800

   Pigs

      At birth

1-2

                300-600

      At weaning

2-3

                600-900

CATTLE (Dairy and Beef)

   Cows and Heifers

      2-3 wks pre -partum

8-10

             2400-3000

      At calving

8-10

             2400-3000

   Calves

      At birth

4-6

             1200-1800

      At weaning

4-6

             1200-1800

   Yearlings

5-6

             1500-1800

SHEEP

   Ewes

      2-3 wks pre-partum

4-5

             1200-1500

      At lambing

4-5

             1200-1500

   Lambs

      At birth

2-3

                600-900

      At weaning

2-3

                600-900

   Finishing Lambs

3-4

              900-1200


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



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


Warning



Do not add water to solution. Not for human use. Keep out of reach of children.


Storage And Handling



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

TAKE TIME OBSERVE LABEL DIRECTIONS


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