Ibuprofen 400 MG Oral Tablet

INDICATIONS & 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.

Polygen Pharmaceuticals LLC

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

9 years ago

ROUND WHITE 121

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 52605-121-01) Bottles of 500 (NDC 52605-121-05) 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 100 (NDC 52605-122-01) Bottles of 500 (NDC 52605-122-05) 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 100 (NDC 52605-123-01) Bottles of 500 (NDC 52605-123-05) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Rx only Manufactured for: PolyGen Pharmaceuticals LLC. Edgewood, NY 11717, USA Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India R106/11

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