LEVOXINE- levoxine powder 
First Priority Incorporated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Levoxine​ Powder

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

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.

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

USE ONLY AS DIRECTED

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Net Contents:

1 lb (453.6 grams), Reorder No. NS190PC

10 lb (4.5 kg), Reorder No. NS191PC

USE ONLY AS DIRECTED

Made in U.S.A.

Manufactured By:

First Priority, Inc., Elgin, IL 60123

www.prioritycare.com

NOT RETURNABLE IF OUTDATED

1.0 lb (453.6 g) jar

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10 lb (4.5 kg) pail

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LEVOXINE 
levoxine powder
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58829-278
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1000 mg  in 453.6 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58829-278-16453.6 g in 1 JAR
2NDC:58829-278-074500 g in 1 PAIL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2008
Labeler - First Priority Incorporated (179925722)
Registrant - First Priority Incorporated (179925722)
Establishment
NameAddressID/FEIBusiness Operations
First Priority Incorporated179925722manufacture

Revised: 9/2018
Document Id: 3f2065cc-8c05-4a8c-b74c-09f42f8d6154
Set id: db8d69e1-44d8-4598-8614-5e84da1fc1c3
Version: 5
Effective Time: 20180907
 
First Priority Incorporated