Label: THYROZINE- levoxine powder
- NDC Code(s): 57319-455-27, 57319-455-43
- Packager: PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.
- 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 January 19, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- KEEP OUT OF REACH OF CHILDREN
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 Thyrozine 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 Thyrozine Powder).
- STORAGE CONDITIONS:
- Net Contents:
- INFORMATION FOR OWNERS/CAREGIVERS
- 1 lb (453.6 g)
- 10 lbs (4.5 Kg)
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57319-455 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 1 g in 453.6 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57319-455-27 12 in 1 CASE 1 453.6 g in 1 JAR 2 NDC:57319-455-43 4536 g in 1 PAIL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/19/2018 Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039) Establishment Name Address ID/FEI Business Operations FIRST PRIORITY INCORPORATED 179925722 api manufacture, manufacture, label