THYROVET- levothyroxine sodium powder

ThyroVet by

Drug Labeling and Warnings

ThyroVet by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Neogen Corporation-Mercer Rd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​VETone®

​ThyroVet™

(Levothyroxine Sodium USP 0.22%)

​Powder

For animl use only.

Keep out of the reach of children.

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

​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 ThyroVet™ 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 individual horses on thyroid supplementation.  Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

​ADMINISTRATION:

ThyroVet™ 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 ThyroVet™ Powder to the ration slightly moisten the grain with water or a liquid supplement.

​ACTIVE INGREDIENTS:

Each pound (453.6 g) contains:

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

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

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

​STORAGE:

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

TAKE TIME

OBSERVE LABEL DIRECTIONS

Lot No.:

Exp. Date:

Manufactured by:

Neogen Corporation

Lexington, KY 40511

Distributed by: MWI

Boise, ID 83705

(888) 694-8381

www.VetOne.net

Rev. 02/13

MADE IN USA

​DISPLAY PANEL VETONE THYROVET POWDER 1 LB

​NDC ​13985-549-50

1 Lb

​VETone®

​ThyroVet™

(Levothyroxine Sodium USP 0.22%)

​Powder

For animl use only.

Keep out of the reach of children.

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

V1510017

Net Contents: 1 lb (453.6 g)

​DISPLAY PANEL VETONE THYROVET 10 LB

​NDC ​13985-549-51

10 Lb

​VETone®

​ThyroVet™

(Levothyroxine Sodium USP 0.22%)

Powder

For animal use only.

Keep out of the reach of children.

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

​V1 ​510018

Net Contents:  10 lb (4.536 kg)

INGREDIENTS AND APPEARANCE

THYROVET 
levothyroxine sodium powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-549
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: 13985-549-50	453.6 g in 1 BOTTLE, PLASTIC
2	NDC: 13985-549-51	4536 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/25/2013

Labeler - MWI/VetOne (019926120)

Registrant - Neogen Corporation-Mercer Rd (042125879)

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