mesalamine 1200 MG Delayed Release Oral Tablet

1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are indicated for the: Induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. Treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine is an aminosalicylate indicated for the: Induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) Treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. ( 1 )

Actavis Pharma, Inc.

FDA Reported Adverse Reactions
`[1] off label use` `[2] fatigue` `[3] drug ineffective` `[4] nausea` `[5] diarrhoea` `[6] dyspnoea` `[7] pyrexia` `[8] pneumonia` `[9] death` `[10] vomiting`

4 years ago

OVAL RED WPI 2245

16 HOW SUPPLIED/STORAGE AND HANDLING

MESALAMINE delayed-release tablets, USP are available as red-brown, oval shaped, coated tablets containing 1.2 g

MESALAMINE, USP and imprinted with black ink “ WPI 2245 ” on one side and plain on the other side. NDC 0591-2245-22 (Bottle of 120) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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mesalamine 1200 MG Delayed Release Oral Tablet

FDA Reported Adverse Reactions [1] off label use [2] fatigue [3] drug ineffective [4] nausea [5] diarrhoea [6] dyspnoea [7] pyrexia [8] pneumonia [9] death [10] vomiting

OVAL RED WPI 2245

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FDA Reported Adverse Reactions
`[1] off label use` `[2] fatigue` `[3] drug ineffective` `[4] nausea` `[5] diarrhoea` `[6] dyspnoea` `[7] pyrexia` `[8] pneumonia` `[9] death` `[10] vomiting`