VITAMIN E-AD-300- alpha tocopherol vitamin a vitamin d3 injection

Vitamin E-AD-300 by

Drug Labeling and Warnings

Vitamin E-AD-300 by is a Animal medication manufactured, distributed, or labeled by Agri Laboratories, Inc., Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

INJECTABLE TOCOPHEROL WITH A+D

(Vitamin A, D3 and E)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INTRAMUSCULAR OR SUBCUTANEOUS ONLY

TAKE TIME OBSERVE LABEL DIRECTIONS

ADMINISTRATION AND DOSAGE

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

 SUGGESTED DOSAGE                           mL

 CATTLE (Diary and Beef)

            Cows and Heifers

               2-3 wks pre-partum ..................... 6-10

               At calving ................................... 8-10

               End of lactation ........................... 8-10

            Calves

               At birth ....................................... 4-6

               At weaning .................................. 4-6

               Yearlings ..................................... 5-6

CAUTION

Anaphylactoid or allergic reactions, which have resulted in deaths, have been reported in individual animals as well as entire herds. Should such reactions or hypersensitivity occur, treat immediately with injection of epinephrine and/or antihistamines. Do not exceed recommended dosage. Administration of this product to well-nourished animals may cause hypervitaminosis D, which may result in hypercalcemia and hyperphosphatemia.

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.

Each mL contains:

Active Ingredients: 300 I.U. of vitamin E (as d-alpha-tocopherol, a natural source of vitamin E); 100,000 I.U. Vitamin A Propionate. 10,000 I.U. vitamin D3 Inactive Ingredients: 2% benzyl alcohol (preservative) in a water emulsifiable base.

INDICATIONS

Vitamin E-AD-300 is a clear, sterile, non-aqueous solution of vitamin A, vitamin D3 and vitamin E. The product is intended as a supplemental source of vitamins A, D, and E.

Natural vitamin A (carotenes), and tocopherols can be destroyed in feedstuffs through processing, ensiling and storage. Due to these losses, reduced intakes of fat-soluble vitamins can occur in animals maintained in continual confinement compared to animals allowed to graze lush pasture. Intramuscular or subcutaneous injections offer an efficient and rapid method to increase vitamin A, vitamin D and vitamin E status of animals.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITAMIN E-AD-300 
alpha tocopherol vitamin a vitamin d3 injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57561-413
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-	201 mg  in 1 mL
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	3.6 mg  in 1 mL
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)	VITAMIN D	2.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57561-413-05	250 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2008

Labeler - Agri Laboratories, Inc. (155594450)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc.		147979082	manufacture, api manufacture, analysis