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Animal NDC 11695-7014-2 Levothyroxine Powder

Levothyroxine Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-7014-2
Proprietary Name Levothyroxine Powder What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Levothyroxine Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Covetrus North America
Product Type Prescription Animal Drug
Usage Information
    Indications: For use in horses for correction of conditions associated with low circulating thyroid hormone (hypothyroidism).
Active Ingredient(s)
  • Levothyroxine Sodium
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Levothyroxine Powder Images

Levothyroxine Powder Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



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)




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.