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:

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:

A) Methimazole Tablets USP 5mg
B) Methimazole Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Methimazole Tablets USP 5mg
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:

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.