Label: THYRO-L- levothyroxine sodium powder

  • NDC Code(s): 11789-048-10, 11789-048-20
  • Packager: LLOYD, Inc. of Iowa
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 27, 2023

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  • VETERINARY INDICATIONS

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

  • DOSAGE & ADMINISTRATION

    Dosage: The suggested initial dose is 0.5 to 3.0 mg levothyroxine sodium (T-4) per 100 pounds body weight (1 to 6 mg per 100 kg) once per day or in divided doses. Response to the administration of Thyro-L should be evaluated clinically until an adequate maintenance dose is established. In most horses, this is usually in the range of 6 to 36 mg (½ to 3 level teaspoons) total daily dose of T-4. Serum T-3 and T-4 values can vary greatly among individual horses on thyroid supplementation. Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity.

  • DOSAGE & ADMINISTRATION

    Administration: For oral dosing as directed by a veterinarian.

  • WARNINGS

    Warning: Use with caution in 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.

  • SAFE HANDLING WARNING

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

  • Active Ingredient per pound (453.6 g):

    Levothyroxine Sodium, USP0.22% (1,000 mg)

    One level teaspoonful contains approximately 12 mg of T-4.

    One level tablespoonful contains approximately 36 mg of T-4.

    Teaspoon measure included.

  • SPL UNCLASSIFIED SECTION

    IMPORTANT
    KEEP OUT OF REACH OF CHILDREN

  • STORAGE AND HANDLING

    Store at controlled room temperature 20°-25°C (68°-77°F) with excursions allowed between 15° and 30°C (59° and 86°F). Protect from light and moisture.

  • SPL UNCLASSIFIED SECTION

    Image

    LLOYD, Inc.
    Shenandoah, Iowa 51601 USA

    List No. 0481
    Rev. 0623

  • PRINCIPAL DISPLAY PANEL - 453.6 g Bottle Label

    LLOYD®

    Thyro-L®

    Levothyroxine sodium powder, USP
    for horses

    Net wt: One Pound (453.6 g)

    PRINCIPAL DISPLAY PANEL - 453.6 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    THYRO-L 
    levothyroxine sodium powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11789-048
    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
    Product Characteristics
    ColorGRAY (Gray powder) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11789-048-10453.6 g in 1 BOTTLE, PLASTIC
    2NDC:11789-048-204536 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/25/1990
    Labeler - LLOYD, Inc. of Iowa (962286535)
    Registrant - LLOYD, Inc. of Iowa (007281942)
    Establishment
    NameAddressID/FEIBusiness Operations
    LLOYD, Inc. of Iowa962286535LABEL, PACK, MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    LLOYD, Inc. of Iowa007281942ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Peptido GmbH327335410API MANUFACTURE