GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mesalamine Prolonged Release Tablets IP 500mg
B) Mesalamine Prolonged Release Tablets IP 800mg
C) Mesalamine Prolonged Release Tablets IP 1200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mesalamine Prolonged Release Tablets IP 500mg
Each film-coated Prolonged Release tablet contains:
Mesalamine IP …………………500mg
Excipients……………………………..q.s.
Colour: Iron Oxide Red and Ferric Oxide Red

B) Mesalamine Prolonged Release Tablets IP 800mg
Each film-coated Prolonged Release tablet contains:
Mesalamine IP …………………800mg
Excipients……………………………..q.s.
Colour: Iron Oxide Red and Ferric Oxide Red

C) Mesalamine Prolonged Release Tablets IP 1200mg
Each film-coated Prolonged Release tablet contains:
Mesalamine IP …………………1200mg
Excipients……………………………...q.s.
Colour: Iron Oxide Red and Ferric Oxide Red USP-NF

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:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A SPECIALIST.

STORAGE & DOSAGE:

Storage: Store below 25 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician

Mesalamine Prolonged Release Tablets IP 500mg Technical Specification:

Product Name: Mesalamine Prolonged Release Tablets IP
Brand Name: Meslataj-PR
Strength: 1200mg, 800mg, 500mg
Dosage Form: Tablets (Prolonged Release)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Anti-inflammatory, Gastroenterological
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 below 25°C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Mesalamine Prolonged Release Tablets IP 500mg
  • B) Mesalamine Prolonged Release Tablets IP 800mg
  • C) Mesalamine Prolonged Release Tablets IP 1200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Mesalamine Prolonged Release Tablets IP 500mg
    Each film-coated Prolonged Release tablet contains:
    Mesalamine IP …………………500mg
    Excipients……………………………..q.s.
    Colour: Iron Oxide Red and Ferric Oxide Red
  • B) Mesalamine Prolonged Release Tablets IP 800mg
    Each film-coated Prolonged Release tablet contains:
    Mesalamine IP …………………800mg
    Excipients……………………………..q.s.
    Colour: Iron Oxide Red and Ferric Oxide Red
  • C) Mesalamine Prolonged Release Tablets IP 1200mg
    Each film-coated Prolonged Release tablet contains:
    Mesalamine IP …………………1200mg
    Excipients……………………………..q.s.
    Colour: Iron Oxide Red and Ferric Oxide Red USP-NF

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 & SCHEDULE:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A SPECIALIST.

STORAGE & DOSAGE:

  • Storage: Store below 25 °C.Protect from Light and moisture.
  • Dosage: As directed by the Physician