GENERIC NAME OF MEDICINAL PRODUCT:

A. Mesalamine Delayed Release Tablets USP 1200mg
B. Mesalamine Delayed Release Tablets USP 800mg
C. Mesalamine Delayed Release Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mesalamine Delayed Release Tablets USP 1200mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………1200mg
Excipients…………………………q.s.
Colour: Iron Oxide Red

B. Mesalamine Delayed Release Tablets USP 800mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………800mg
Excipients…………………………q.s.
Colour: Ferric Oxide Red USP-NF

C. Mesalamine Delayed Release Tablets USP 400mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………400mg
Excipients…………………………q.s.
Colour: Iron Oxide Yellow


THERAPEUTIC INDICATION:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. They are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: To be sold by retail on the prescription of a Specialist/Gastroenterologist.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

STORAGE: Store in between 20°C to 25°C.
Excursion are permitted 15°C to 30°C.
Keep in cool & Dry place.
Protect from Light.
Read enclosed leaflet before use.
DOSAGE: As directed by physician.

Mesalamine Delayed Release Tablets USP 400mg Technical Specification:

Product Name:Mesalamine Delayed Release Tablets USP 400mg
Brand Name:Meslataj-DR
Strength:1200mg, 800mg, 400mg
Dosage Form:Delayed Release Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:10s, 15s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Treatment of ulcerative colitis
Indication: Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). They are indicated for the maintenance of remission of ulcerative colitis in adults.
Storage:Store in between 20°C to 25°C. Excursion are permitted 15°C to 30°C. Keep in cool & Dry place. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mesalamine Delayed Release Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Mesalamine Delayed Release Tablets USP 400mg
    Each film-coated delayed release tablet contains:
    Mesalamine USP …………………400mg
    Excipients…………………………q.s.
    Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. They are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

WARNING: To be sold by retail on the prescription of a Specialist/Gastroenterologist.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

STORAGE: Store in between 20°C to 25°C. Excursion are permitted 15°C to 30°C. Keep in cool & Dry place.  Protect from Light.

Read enclosed leaflet before use.

Dosage: As directed by physician.