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Animal NDC 58829-278-16 Levoxine

Animal Product Information

Field Name Field Value
Animal NDC Code 58829-278-16
Proprietary Name Levoxine 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 Levoxine 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 First Priority Incorporated
Product Type Prescription Animal Drug
Usage Information
    For use in horses and ponies for correction of conditions associated with low circulating thyroid hormone (hypothyrodism).
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.

Levoxine Images

Levoxine 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



Information For Owners/Caregivers



A Palatable Supplement for the Correction of Conditions Associated with Hypothyroidism in Horses and Ponies.

USE ONLY AS DIRECTED

Made in U.S.A.

Manufactured By:

First Priority, Inc., Elgin, IL 60123

www.prioritycare.com

NOT RETURNABLE IF OUTDATED


Warnings And Precautions



WARNING: 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


Indications:



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


Dosage:



Doses should be individualized and animals should be monitored daily for clincial signs of hyperthyroidism or hypersensitivity.  Suggested initial doses are 1-10 mg levothyroxine sodium (T4)/100 lb body weight (2-20 mg/100 kg) once per day or in divided doses.  Response to the administration of Levoxine™ Powder should be evaluated clinically every week until an adequate maintenance dose is established.  In most horses, this is usually in the range of 35 to 100 mg total daily dose of T4 (1-3 level tablespoonfuls Levoxine™ Powder).


Ingredients:



Each pound (453.6 g) contains:

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

One level teaspoonful contains 12 mg of T4: one level tablespoonful contains 36 mg of T4.


Warnings



WARNING: Administer with caution to animals with clincially 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.


Storage And Handling



STORAGE: Store at controlled room temperature between 15° - 30°C (59° - 86°F).  Keep container tightly closed when not in use.

USE ONLY AS DIRECTED


How Supplied



Net Contents:

1 lb (453.6 grams), Reorder No. NS190PC

10 lb (4.5 kg), Reorder No. NS191PC


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