indomethacin 75 MG Extended Release Oral Capsule

1 INDICATIONS AND USAGE Indomethacin extended-release capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe ankylosing spondylitis. Moderate to severe osteoarthritis. Acute painful shoulder (bursitis and/or tendinitis). ( 1 )

Amneal Pharmaceuticals LLC

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

3 years ago

CAPSULE 506 AMNEAL

16 HOW SUPPLIED/STORAGE AND HANDLING

INDOMETHACIN Extended-Release capsules USP, 75 mg are hard gelatin capsules with natural clear body imprinted “506” and blue translucent cap imprinted “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-506-03 Bottles of 60: NDC 65162-506-06 Bottles of 90: NDC 65162-506-09 Bottles of 100: NDC 65162-506-10 Bottles of 500: NDC 65162-506-50 Bottles of 1000: NDC 65162-506-11 Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Contains color additives, including FD&C yellow No. 5 (tartrazine).

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