sulindac tablet

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac is 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 tablets USP 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).

epic pharma, llc

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] nausea` `[4] dyspnoea` `[5] diarrhoea` `[6] off label use` `[7] pain` `[8] headache` `[9] vomiting` `[10] acute kidney injury`

5 years ago

OVAL YELLOW E 11

5 years ago

E 11 OVAL YELLOW

HOW SUPPLIED

SULINDAC Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100. NDC 42806-018-05 in bottles of 500. NDC 42806-018-10 in bottles of 1000.

SULINDAC Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-011-01 in bottles of 100. NDC 42806-011-05 in bottles of 500. NDC 42806-011-10 in bottles of 1000. Storage Store in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/

SULINDAC-Tablet.pdf Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev.01-2023-00 MF018REV01/23 OE1000

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