Ibuprofen 800 MG Oral Tablet

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Ascend Laboratories, LLC

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

9 years ago

OVAL WHITE 123

9 years ago

123 OVAL WHITE

HOW SUPPLIED Ibuprofen tablets are available in the following strengths : 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side) Bottles of 100 (NDC 67877-294-01) Bottles of 500 (NDC 67877-294-05) 600 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottles of 30 (NDC 67877-295-30) Bottles of 50 (NDC 67877-295-50) Bottles of 100 (NDC 67877-295-01) Bottles of 500 (NDC 67877-295-05) 800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) Bottles of 30 (NDC 67877-296-30) Bottles of 50 (NDC 67877-296-50) Bottles of 100 (NDC 67877-296-01) Bottles of 500 (NDC 67877-296-05) Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature] Rx only Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Rev. 07/13

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