Label: THYROZINE- levoxine powder

  • NDC Code(s): 57319-455-27, 57319-455-43
  • Packager: PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 January 19, 2018

If you are a consumer or patient please visit this version.

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN
    WARNING: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • INDICATIONS:

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

  • DOSAGE:

    Doses should be individualized and animals should be monitored daily for clinical 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 Thyrozine 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 Thyrozine Powder).

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  • COMPOSITION:

    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 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.

  • STORAGE CONDITIONS:

    Do not store above 30°C (86°F). Keep lid tightly closed and store in a dry location.
    USE ONLY AS DIRECTED

  • Net Contents:

    1 lb (453.6 g)

    10 lbs (4.5 Kg)

  • INFORMATION FOR OWNERS/CAREGIVERS

    Trademarks are property of Clipper Distributing Company, LLC
    Manufactured by:
    First Priority, Inc.
    Elgin, IL U.S.A.

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  • 1 lb (453.6 g)

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  • 10 lbs (4.5 Kg)

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  • INGREDIENTS AND APPEARANCE
    THYROZINE 
    levoxine powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-455
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1 g  in 453.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-455-2712 in 1 CASE
    1453.6 g in 1 JAR
    2NDC:57319-455-434536 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/19/2018
    Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722api manufacture, manufacture, label