Methimazole Tablets USP 10mg Technical Specification:
| Product Name: | Methimazole Tablets USP 10mg |
| Brand Name: | Generic |
| Strength: | (5mg), (10mg) |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Hypothyroidism |
| Indication: | Methimazole is used to treat hyperthyroidism, a condition that occurs when the thyroid gland produces too much thyroid hormone. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Methimazole Tablets USP 5mg
- Methimazole Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Methimazole Tablets USP 5mg
Each uncoated tablet contains:
Methimazole USP…………………….5mg
Excipients…………………………………q.s.
Colours: Quinizarine green ss
- Methimazole Tablets USP 10mg
Each uncoated tablet contains:
Methimazole USP…………………….10mg
Excipients…………………………………q.s.
Colours: Red oxide of iron
THERAPEUTIC INDICATIONS:
Methimazole is used to treat hyperthyroidism, a condition that occurs when the thyroid gland produces too much thyroid hormone.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of an Endocrinologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant container.
Dosage: As directed by the Endocrinologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Methimazole Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Methimazole USP…………………….5mg
Excipients…………………………………q.s.
Colours: Quinizarine green ss
B) Methimazole Tablets USP 10mg
Each uncoated tablet contains:
Methimazole USP…………………….10mg
Excipients…………………………………q.s.
Colours: Red oxide of iron
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of an Endocrinologist only.
STORAGE & DOSAGE:
Dispense in tight, light-resistant container.
Dosage: As directed by the Endocrinologist.

