THYROSYN- levothyroxine sodium powder

Thyrosyn by

Drug Labeling and Warnings

Thyrosyn by is a Animal medication manufactured, distributed, or labeled by Vedco, Inc, Neogen Corporation-Mercer. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

EQUI-PHAR

THYROSYN

POWDER

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

​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. The recommended daily dose is ½ to 2 ½ level teaspoons for a 500 kg (1100 lb) horse.

Response to the administration of Thyrosyn Powder should be evaluated clinically until an adequate maintenance dose is established. In most horses, this is usually in the range of 6 to 36 mg (½ to 3 level teaspoons) total daily dose of T-4. Serum T-3 and T-4 values can vary greatly among individual horses on thyroid supplementation. Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

​ADMINISTRATION:

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

SPL UNCLASSIFIED SECTION

Manufactured by

Neogen Corporation

Lexington, KY 40511

Distributed By

​Vedco, INC.

​St. Joseph, MO 64507

​FOR USE IN HORSES ONLY

​ACTIVE INGREDIENTS

Each pound (453.6 g) contains:

Levothyroxine Sodium USP:..........................0.22% (1.0 g)

One level teaspoon contains: ...................... 12 mg of T-4

One level tablespoon contains: .................... 36 mg of T-4

​PRECAUTIONS:

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. ​

​TAKE TIMEOBSERVE LABEL DIRECTIONS

SPL UNCLASSIFIED SECTION

Made in USA

L821-11309

Lot No.

Exp. Date

PRINCIPAL DISPLAY PANEL - 1 Pound Bottle

NDC: 50989-172-26

EQUI-PHAR

THYROSYN

POWDER

NET CONTENTS: 1 LB. (453.6 g)

VEDCO

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

THYROSYN 
levothyroxine sodium powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-172
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: 50989-172-26	453.6 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/08/2012

Labeler - Vedco, Inc (021634266)

Registrant - Neogen Corporation-Mercer (042125879)

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