| Product Name: | Mesalamine Delayed Release Tablets USP |
| Brand Name: | Meslataj-DR |
| Strength: | 400mg, 800mg, 1.2g |
| 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: | Antidiarrheal ,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
- Mesalamine Delayed Release Tablets USP 800mg
- Mesalamine Delayed Release Tablets USP 1.2g
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 - Mesalamine Delayed Release Tablets USP 800mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………800mg
Excipients…………………………q.s.
Colour: Iron Oxide Yellow - Mesalamine Delayed Release Tablets USP 1.2g
Each film-coated delayed release tablet contains:
Mesalamine USP …………………1.2g
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.