Label: THYROKARE- levothyroxine sodium powder

  • NDC Code(s): 59051-9127-4
  • Packager: Neogen Corporation-Mercer Rd
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 1, 2018

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

  • FOR ANIMAL USE ONLY

  • Indications:

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

  • Dosage:

    The suggested initial dose is 0.5 to 3.0 mg 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 ThyroKare 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 inidividual horses on thyroid supplementation. Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

    Administration:

    ThyroKare 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 ThyroKare Powder to the ration, slightly moisten the grain with water or a liquid supplement.

  • KEEP OUT OF REACH OF CHILDREN

  • Active Ingredients:Each pound (453.6 g) contains:Levothyroxine Sodium USP.....................0.22% (1.0 g)One teaspoon contains:.........................12 mg of T-4One tablespoon contains:......................36 mg of T-4

  • Precaution:

    Store at 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) and protect from light.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Lot No.:

    Exp. Date:

    Manufactured by:

    Neogen Corporation

    Lexington, KY 40511

    859-254-1221 or 800-621-8829

    Made in USA

  • PRINCIPAL DISPLAY PANEL - 1 pound bottle

    NDC: 59051-9127-4

    ThyroKare Powder™

    Levothyroxine Sodium USP

    (0.22%)

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    NEOGEN.Vet

    Net Contents: 1 lb (453.6 g)

    L3382-0716

    Thyrokare 1lb

  • INGREDIENTS AND APPEARANCE
    THYROKARE 
    levothyroxine sodium powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59051-9127
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1 g  in 453.6 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59051-9127-4453.6 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2016
    Labeler - Neogen Corporation-Mercer Rd (042125879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neogen Corporation-Mercer Rd042125879analysis, manufacture, label
    Establishment
    NameAddressID/FEIBusiness Operations
    Peptido GmbH327335410api manufacture