Levothyroxine by Butler Animal health Supply, LLC dba Covetrus North America / FIRST PRIORITY INCORPORATED LEVOTHYROXINE powder

Levothyroxine by

Drug Labeling and Warnings

Levothyroxine by is a Animal medication manufactured, distributed, or labeled by Butler Animal health Supply, LLC dba Covetrus North America, FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

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.

KEEP OUT OF REACH OF CHILDREN

For animal use only
Keep out of reach of children

HOW SUPPLIED

1 lb (453.6 g)

10 lb (4.5 kg)

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.

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

INFORMATION FOR OWNERS/CAREGIVERS

Reorder #017559 (1 lb)

Reorder #017560 (10 lb)

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

AH-017559-02
REV: 1019 (1 lb)

AH-017560-02
REV: 1019 (10 lb)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEVOTHYROXINE 
levothyroxine powder

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	1.0 g  in 453.6 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-2212-1	12 in 1 JAR
1		453.6 g in 1 JAR
2	NDC: 11695-2212-2	4500 g in 1 PAIL

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	Business Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture, label