Levothyroxine: Product Information

LEVOTHYROXINE- levothyroxine sodium powder
Butler Animal health Supply, LLC dba Covetrus North America

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.

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

1 lb (453.6 g)

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 Levothyroxine 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 Levothyroxine powder).

Administration:

Levothyroxine powder may be top dressed or mixed with the daily ration.

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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:

Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep lid tightly closed and store in a dry location.

USE ONLY AS DIRECTED

Reorder #017559
Questions? (855) 724-3461
Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

AH-017559-02
REV: 1019

LEVOTHYROXINE levothyroxine powder

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-2212 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 1.0 g in 453.6 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11695-2212-1 12 JAR in 1 JAR contains a JAR 1 453.6 g in 1 JAR This package is contained within the JAR (11695-2212-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/26/2019

Labeler — Butler Animal health Supply, LLC dba Covetrus North America (603750329)

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

Revised: 11/2019 Butler Animal health Supply, LLC dba Covetrus North America