THYROZINE- levoxine powder 
PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Thyrozine Powder

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

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).

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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)

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

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1 lb (453.6 g)

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10 lbs (4.5 Kg)

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THYROZINE 
levoxine powder
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-455
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1 g  in 453.6 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57319-455-2712 in 1 CASE
1453.6 g in 1 JAR
2NDC:57319-455-434536 g in 1 PAIL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/19/2018
Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039)
Establishment
NameAddressID/FEIBusiness Operations
FIRST PRIORITY INCORPORATED179925722api manufacture, manufacture, label

Revised: 1/2018
Document Id: 3632a374-f7d9-436f-b2d7-00e6415680ae
Set id: a0920229-20ed-464d-b903-7405db88bd18
Version: 1
Effective Time: 20180119
 
PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.