GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Norethisterone Tablets IP 0.35mg
B. Norethisterone Tablets IP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Norethisterone Tablets IP 0.35mg
Each uncoated tablet contains:
Norethisterone IP……………….0.35mg
Excipients……………………………q.s

B) Norethisterone Tablets IP 5mg
Each uncoated tablet contains:
Norethisterone IP……………….5mg
Excipients……………………………q.s

THERAPEUTIC INDICATIONS:

Norethisterone is used in heavy menstrual bleeding, pain during menstruation, endometriosis and Premenstrual syndrome (PMS).

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablets to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG-WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the physician.

Norethisterone Tablets IP 5mg Technical Specification:

Product Name: Norethisterone Tablets IP 5mg
Brand Name: Generic
Strength: 0.35mg, 5mg
Dosage Form: Tablets (uncoated)
Route of Administration: Via Oral Route
Packing: 5 Strips of 10 Tablets each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Progestins
Indication: Norethisterone is used in heavy menstrual bleeding, pain during menstruation, endometriosis and Premenstrual syndrome (PMS).
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Norethisterone Tablets IP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Norethisterone Tablets IP 5mg
    Each uncoated tablet contains:
    Norethisterone IP……………….5mg
    Excipients………………………..q.s

THERAPEUTIC INDICATIONS:

 Norethisterone is used in heavy menstrual bleeding, pain during menstruation, endometriosis and Premenstrual syndrome (PMS).

CAUTION & SCHEDULE:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablets to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG-WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage: As directed by the physician.