THYROZINE- levoxine powder

Thyrozine by

Drug Labeling and Warnings

Thyrozine by is a Animal medication manufactured, distributed, or labeled by PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC., 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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
WARNING: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS:

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

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 Thyrozine 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 Thyrozine Powder).

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 clinically 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 CONDITIONS:

Do not store above 30°C (86°F). Keep lid tightly closed and store in a dry location.
USE ONLY AS DIRECTED

Net Contents:

1 lb (453.6 g)

10 lbs (4.5 Kg)

INFORMATION FOR OWNERS/CAREGIVERS

Trademarks are property of Clipper Distributing Company, LLC
Manufactured by:
First Priority, Inc.
Elgin, IL U.S.A.

1 lb (453.6 g)

10 lbs (4.5 Kg)

INGREDIENTS AND APPEARANCE

THYROZINE 
levoxine powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57319-455
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	1 g  in 453.6 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-455-27	12 in 1 CASE
1		453.6 g in 1 JAR
2	NDC: 57319-455-43	4536 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/19/2018

Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST PRIORITY INCORPORATED		179925722	api manufacture, manufacture, label