Label: LEVOXINE powder

  • NDC Code(s): 58829-278-07, 58829-278-16
  • Packager: First Priority Incorporated
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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.

Drug Label Information

Updated September 7, 2018

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  • INFORMATION FOR OWNERS/CAREGIVERS

    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.

  • 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

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  • HOW SUPPLIED

    Net Contents:

    1 lb (453.6 grams), Reorder No. NS190PC

    10 lb (4.5 kg), Reorder No. NS191PC

  • INFORMATION FOR OWNERS/CAREGIVERS

    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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  • INGREDIENTS AND APPEARANCE
    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