Levoxine by First Priority Incorporated LEVOXINE powder

Levoxine by

Drug Labeling and Warnings

Levoxine by is a Animal medication manufactured, distributed, or labeled by First Priority Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INFORMATION FOR OWNERS/CAREGIVERS

A Palatable Supplement for the Correction of Conditions Associated with Hypothyroidism in Horses and Ponies.

WARNING: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For Animal Use Only Keep Out of Reach of Children

INDICATIONS:

For use in horses and ponies for correction of conditions associated with low circulating thyroid hormone (hypothyrodism).

DOSAGE:

Doses should be individualized and animals should be monitored daily for clincial signs of hyperthyroidism or hypersensitivity.  Suggested initial doses are 1-10 mg levothyroxine sodium (T4)/100 lb body weight (2-20 mg/100 kg) once per day or in divided doses.  Response to the administration of Levoxine™ Powder should be evaluated clinically every week until an adequate maintenance dose is established.  In most horses, this is usually in the range of 35 to 100 mg total daily dose of T4 (1-3 level tablespoonfuls Levoxine™ Powder).

INGREDIENTS:

Each pound (453.6 g) contains:

Levothyroxine Sodium USP  ........................................  0.22% (1.0 g)

One level teaspoonful contains 12 mg of T4: one level tablespoonful contains 36 mg of T4.

WARNINGS

WARNING: Administer with caution to animals with clincially significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.  Use in pregnant mares has not been evaluated.

STORAGE AND HANDLING

STORAGE: Store at controlled room temperature between 15° - 30°C (59° - 86°F).  Keep container tightly closed when not in use.

USE ONLY AS DIRECTED

HOW SUPPLIED

Net Contents:

1 lb (453.6 grams), Reorder No. NS190PC

10 lb (4.5 kg), Reorder No. NS191PC

INFORMATION FOR OWNERS/CAREGIVERS

USE ONLY AS DIRECTED

Made in U.S.A.

Manufactured By:

First Priority, Inc., Elgin, IL 60123

www.prioritycare.com

NOT RETURNABLE IF OUTDATED

1.0 lb (453.6 g) jar

10 lb (4.5 kg) pail

INGREDIENTS AND APPEARANCE

LEVOXINE 
levoxine powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58829-278
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	1000 mg  in 453.6 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58829-278-16	453.6 g in 1 JAR
2	NDC: 58829-278-07	4500 g in 1 PAIL

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

Labeler - First Priority Incorporated (179925722)

Registrant - First Priority Incorporated (179925722)

Establishment
Name	Address	ID/FEI	Business Operations
First Priority Incorporated		179925722	manufacture