mesalamine 800 mg

1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. (1) Limitation of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established (1)

amneal pharmaceuticals llc

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] off label use` `[4] fatigue` `[5] nausea` `[6] pain` `[7] diarrhoea` `[8] headache` `[9] incorrect route of drug administration` `[10] pneumonia`

2 weeks ago

OVAL RED AN360

16 HOW SUPPLIED/STORAGE AND HANDLING

MESALAMINE delayed-release tablets, USP 800 mg are available as red to dark red, modified oval, film-coated, biconvex, unscored tablets printed with AN360 in black ink on one side and plain on the other side. They are supplied as follows: Bottles of 180 tablets with child-resistant closure: NDC 65162-360-18 Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks. Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]

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mesalamine 800 mg

FDA Reported Adverse Reactions [1] dyspnoea [2] drug ineffective [3] off label use [4] fatigue [5] nausea [6] pain [7] diarrhoea [8] headache [9] incorrect route of drug administration [10] pneumonia

OVAL RED AN360

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FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] off label use` `[4] fatigue` `[5] nausea` `[6] pain` `[7] diarrhoea` `[8] headache` `[9] incorrect route of drug administration` `[10] pneumonia`