LEVOTHYROXINE POWDER- levothyroxine sodium powder

Levothyroxine Powder by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Dosage: The suggested initial dose is 0.5 to 3.0mg 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 Levothyroxine 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. Doses should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

Administration: Levothyroxine 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 Levothyroxine powder to the ration, slightly moisten the grain with water or a liquid supplement.

COMPONENTS

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

In a palatable limestone base with vanilla flavoring.

STORAGE AND HANDLING

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

WARNINGS AND PRECAUTIONS

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

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

Made in USA of U.S. and imported materials

PRINCIPAL DISPLAY PANEL 1 Pound Jar

NDC: 11695-7014-01

Levothyroxine Powder
Levothyroxine sodium USP (0.22%)


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


CAUTION: 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

Net Contents: 1 lb (453.6 g)

PRINCIPAL DISPLAY PANEL 10 Pound Pail

NDC: 11695-7014-02

Levothyroxine Powder
Levothyroxine sodium USP (0.22%)

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

CAUTION: 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

Net Contents: 10 lbs (4.536 kg)

INGREDIENTS AND APPEARANCE

LEVOTHYROXINE POWDER 
levothyroxine sodium powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-7014
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: 11695-7014-1	453.6 g in 1 JAR
2	NDC: 11695-7014-2	4536 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2018

Labeler - Covetrus North America (603750329)

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

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