THYROKARE- levothyroxine sodium powder

ThyroKare by

Drug Labeling and Warnings

ThyroKare by is a Animal medication manufactured, distributed, or labeled by Neogen Corporation-Mercer Rd, Peptido GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOR ANIMAL USE ONLY

Indications:

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

Dosage:

The suggested initial dose is 0.5 to 3.0 mg levothyroxine sodium (T-4) per 100 lbs of body weight (1 to 6 mg per 100 kg) once per day or in divided doses. Response to the administration of ThyroKare Powder should be evaluated clinically until an adequate maintenance dose is established. In most horses, the total daily dose of T-4 is in the range of 6 to 36 mg. Serum T-3 and T-4 values can vary greatly among inidividual horses on thyroid supplementation. Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

Administration:

ThyroKare Powder can be administered by mixing the daily dose in the concentrate or by top dressing on the grain, preferably rolled or ground. To facilitate the proper adhesion of ThyroKare Powder to the ration, slightly moisten the grain with water or a liquid supplement.

KEEP OUT OF REACH OF CHILDREN

Active Ingredients:Each pound (453.6 g) contains:Levothyroxine Sodium USP.....................0.22% (1.0 g)One teaspoon contains:.........................12 mg of T-4One tablespoon contains:......................36 mg of T-4 In a palatable limestone base with vanilla flavoring.

Precaution:

Store at 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) and protect from light.

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.

SPL UNCLASSIFIED SECTION

Lot No.:

Exp. Date:

Manufactured by:

Neogen Corporation

Lexington, KY 40511

859-254-1221 or 800-621-8829

animalsafety.neogen.com

Made in USA

PRINCIPAL DISPLAY PANEL 10 pound pail

NDC: 59051-9128-9

ThyroKare™ Equine Powder

Levothyroxine Sodium USP

(0.22%)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NEOGENVet

Net Contents: 10 lb (4.536 kg)

L3396-0816

INGREDIENTS AND APPEARANCE

THYROKARE 
levothyroxine sodium powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 59051-9128
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 g  in 453.6 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59051-9128-9	4536 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2016

Labeler - Neogen Corporation-Mercer Rd (042125879)

Establishment
Name	Address	ID/FEI	Business Operations
Neogen Corporation-Mercer Rd		042125879	analysis, manufacture, label

Establishment
Name	Address	ID/FEI	Business Operations
Peptido GmbH		327335410	api manufacture