Label: LEVOTHYROXINE powder

  • NDC Code(s): 11695-2212-1
  • Packager: Butler Animal health Supply, LLC dba Covetrus North America
  • 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 November 26, 2019

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

  • VETERINARY INDICATIONS

    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.

  • KEEP OUT OF REACH OF CHILDREN

    For animal use only
    Keep out of reach of children

  • HOW SUPPLIED

    1 lb (453.6 g)

  • 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 Levothyroxine 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 Levothyroxine powder).

  • Administration:

    Levothyroxine powder may be top dressed or mixed with the daily ration.

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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:

    Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep lid tightly closed and store in a dry location.

    USE ONLY AS DIRECTED

  • INFORMATION FOR OWNERS/CAREGIVERS

    Reorder #017559
    Questions? (855) 724-3461

    Distributed by:
    Covetrus North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com

    AH-017559-02
    REV: 1019

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LEVOTHYROXINE 
    levothyroxine powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-2212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS1.0 g  in 453.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-2212-112 in 1 JAR
    1453.6 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/26/2019
    Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label