Vitamin E-300 (Tocopherol) Injection [Agri Laboratories, Ltd.] -

VITAMIN E-300 (TOCOPHEROL) INJECTION [AGRI LABORATORIES, LTD.]
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NDC	57561-412-05
Set ID	5fdc7a28-4059-4d18-aa15-23af90d01bb2
Category	OTC ANIMAL DRUG LABEL
Packager	Agri Laboratories, Ltd.
Generic Name
Product Class
Product Number
Application Number

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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

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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITAMIN E-300
tocopherol injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:57561-412
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	ALPHA-TOCOPHEROL	201 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57561-412-05	250 mL in 1 VIAL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/25/2007

Labeler - Agri Laboratories, Ltd. (155594450)

Registrant - Sparhawk Laboratories, Inc. (147979082)

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

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VITAMIN E-300 (TOCOPHEROL) INJECTION [AGRI LABORATORIES, LTD.]

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