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Animal NDC 11789-048-20 Thyro-l

Levothyroxine Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 11789-048-20
Proprietary Name Thyro-l What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Levothyroxine Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Lloyd, Inc. Of Iowa
Product Type Prescription Animal Drug
Usage Information
    Indications: For use in horses for correction of conditions associated with low circulating thyroid hormone (hypothyroidism).
Active Ingredient(s)
  • Levothyroxine Sodium
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Thyro-l Images

Thyro-l Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.

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.


Other



IMPORTANT
KEEP OUT OF REACH OF CHILDREN

LLOYD, Inc.
Shenandoah, Iowa 51601 USA

List No. 0481
Rev. 0623


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.


Principal Display Panel - 453.6 G Bottle Label



LLOYD®

Thyro-L®

Levothyroxine sodium powder, USP
for horses

Net wt: One Pound (453.6 g)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.