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.
Updated November 26, 2019
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- VETERINARY INDICATIONS
- KEEP OUT OF REACH OF CHILDREN
- HOW SUPPLIED
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).
- INFORMATION FOR OWNERS/CAREGIVERS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-2212 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 1.0 g in 453.6 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-2212-1 12 in 1 JAR 1 453.6 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/26/2019 Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329) Establishment Name Address ID/FEI Business Operations FIRST PRIORITY INCORPORATED 179925722 manufacture, label