ibuprofen 400 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.

Amneal Pharmaceuticals of New York LLC

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

8 months ago

ROUND WHITE IP 464

HOW SUPPLIED

IBUPROFEN Tablets, USP are available in the following strengths, colors and sizes: 400 mg white, round, biconvex, aqueous film-coated tablets, debossed "IP 464" on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 53746-464-30 Bottles of 60: NDC 53746-464-60 Bottles of 90: NDC 53746-464-90 Bottles of 100: NDC 53746-464-01 Bottles of 500: NDC 53746-464-05 600 mg white, oval-shaped, biconvex, aqueous film-coated tablets, debossed "IP 465" on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 53746-465-30 Bottles of 50: NDC 53746-465-50 Bottles of 60: NDC 53746-465-60 Bottles of 90: NDC 53746-465-90 Bottles of 100: NDC 53746-465-01 Bottles of 500: NDC 53746-465-05 800 mg white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed "IP 466" on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 53746-466-30 Bottles of 50: NDC 53746-466-50 Bottles of 60: NDC 53746-466-60 Bottles of 90: NDC 53746-466-90 Bottles of 100: NDC 53746-466-01 Bottles of 500: NDC 53746-466-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Dispense in a tight, light-resistant container as defined in the USP. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2021-07

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amneal pharmaceuticals of new york, llc

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