Sulindac 150 MG Oral Tablet

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis * 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5. Acute gouty arthritis * The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care).

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] drug ineffective` `[3] completed suicide` `[4] drug abuse` `[5] nausea` `[6] pain` `[7] fatigue` `[8] drug hypersensitivity` `[9] diarrhoea` `[10] off label use`

4 years ago

ROUND YELLOW MYLAN 427

HOW SUPPLIED Sulindac Tablets, USP are available containing 150 mg or 200 mg of sulindac, USP. The 150 mg tablets are yellow-orange, round, unscored tablets debossed with MYLAN on one side of the tablet and 427 on the other side. They are available as follows: NDC 0378-0427-01 bottles of 100 tablets The 200 mg tablets are yellow-orange, round tablets debossed with MYLAN above the score and 531 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0531-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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Sulindac 150 MG Oral Tablet

FDA Reported Adverse Reactions [1] toxicity to various agents [2] drug ineffective [3] completed suicide [4] drug abuse [5] nausea [6] pain [7] fatigue [8] drug hypersensitivity [9] diarrhoea [10] off label use

ROUND YELLOW MYLAN 427

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FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] drug ineffective` `[3] completed suicide` `[4] drug abuse` `[5] nausea` `[6] pain` `[7] fatigue` `[8] drug hypersensitivity` `[9] diarrhoea` `[10] off label use`