THYROXINE L POWDER- levoxine powder

Thyroxine L Powder by

Drug Labeling and Warnings

Thyroxine L Powder by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, First Priority Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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 clinical 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 Thyroxine L 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 Thyroxine L Powder).

Administration:

Thyroxine L Powder may be top dressed or mixed with the daily ration.

Composition:

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.

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:

Store at controlled room temperature between 15° - 30°C (59° - 86°F).  Keep lid tightly closed and store in a dry location.
USE ONLY AS DIRECTED

Net Weight:

1 lb (453.6 grams) Reorder #017559

10 lb (4.5 kg) Reorder #017560

INFORMATION FOR OWNERS/CAREGIVERS

Questions? (855) 724-3461

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

Manufactured by:
First Priority, Inc.
Elgin, IL 60123

AH-017559-01/AH-017560-01
Rev. 0218

1.0 lb (453.6 g) jar

10 lb (4.5 kg) pail

INGREDIENTS AND APPEARANCE

THYROXINE L POWDER 
levoxine powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-2105
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: 11695-2105-1	12 in 1 CASE
1		453.6 g in 1 JAR
2	NDC: 11695-2105-2	4500 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2013

Labeler - Henry Schein Animal Health (603750329)

Registrant - First Priority Incorporated (179925722)

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