celecoxib 50 MG Oral Capsule
1. INDICATIONS AND USAGE Celecoxib capsules are indicated for: Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ] . 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ] . 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ] . 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [see Clinical Studies (14.4) ] . 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies (14.5) ] . 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies (14.5) ] .
Amneal Pharmaceuticals LLC
CAPSULE ORANGE AMNEAL 817
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16. HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules, 50 mg are supplied as hard gelatin capsules, filled white to off-white granular powder, having swedish orange opaque cap imprinted with “AMNEAL” in black ink and white opaque body reverse printed white with “817” on red band. They are available as follows: Bottles of 60: NDC 65162-817-06
CELECOXIB capsules, 100 mg are supplied as hard gelatin capsules, filled with white to off-white granular powder, having purple opaque cap imprinted with “AMNEAL” in black ink and white opaque body reverse printed white with “818” on light blue band. They are available as follows: Bottles of 100: NDC 65162-818-10 Bottles of 500: NDC 65162-818-50 Bottles of 1000: NDC 65162-818-11
CELECOXIB capsules, 200 mg are supplied as hard gelatin capsules, filled with white to off-white granular powder, having yellow opaque cap imprinted with “AMNEAL” in black ink and white opaque body reverse printed white with “819” on light yellow band. They are available as follows: Bottles of 100: NDC 65162-819-10 Bottles of 500: NDC 65162-819-50 Bottles of 1000: NDC 65162-819-11
CELECOXIB capsules, 400 mg are supplied as hard gelatin capsules, filled with white to off-white granular powder, having green opaque cap imprinted with “AMNEAL” in black ink and white opaque body reverse printed with “820” on light green band. They are available as follows: Bottles of 60: NDC 65162-820-06 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].
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