THYRO-L- levothyroxine sodium powder

Thyro-L by

Drug Labeling and Warnings

Thyro-L by is a Animal medication manufactured, distributed, or labeled by LLOYD, Inc. of Iowa, Peptido GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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.

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: 0.22% (1,000mg)

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 room temperature and protect from light.
Avoid excessive heat (104°F).

SPL UNCLASSIFIED SECTION

LLOYD, Inc.
Shenandoah, Iowa 51601 U.S.A.

List No. 0481
1004

PRINCIPAL DISPLAY PANEL - 453.6 g Bottle Label

LLOYD

Net wt: One Pound (453.6 g)

Thyro-L®

Levothyroxine sodium powder, USP
for horses

INGREDIENTS AND APPEARANCE

THYRO-L 
levothyroxine sodium powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11789-048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM	1000 mg  in 453.6 g

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM SILICATE (UNII: S4255P4G5M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHOXYQUIN (UNII: 9T1410R4OR)
CALCIUM CARBONATE (UNII: H0G9379FGK)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOSE (UNII: J2B2A4N98G)
CORN OIL (UNII: 8470G57WFM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

Product Characteristics
Color	GRAY (Gray powder)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11789-048-10	453.6 g in 1 BOTTLE, PLASTIC
2	NDC: 11789-048-20	4536 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/25/1990

Labeler - LLOYD, Inc. of Iowa (962286535)

Establishment
Name	Address	ID/FEI	Business Operations
LLOYD, Inc. of Iowa		962286535	MANUFACTURE, PACK, LABEL

Establishment
Name	Address	ID/FEI	Business Operations
LLOYD, Inc. of Iowa		007281942	ANALYSIS

Establishment
Name	Address	ID/FEI	Business Operations
Peptido GmbH		327335410	API MANUFACTURE