celecoxib 50 MG Oral Capsule
1 INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are 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) ] .
Actavis Pharma, Inc.
CAPSULE WHITE WPI 50
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB 50 mg capsules are opaque light pink cap printed " WPI " with black ink and opaque white colored body printed " 50 " with black ink containing white colored granular powder, supplied as: NDC Number Size 0591-3982-60 bottle of 60
CELECOXIB 100 mg capsules are opaque light blue cap printed " WPI " with black ink and opaque white colored body printed " 100 " with black ink containing white colored granular powder, supplied as: NDC Number Size 0591-3983-01 bottle of 100 0591-3983-05 bottle of 500
CELECOXIB 200 mg capsules are opaque light yellow cap printed " WPI " with black ink and opaque white colored body printed " 200 " with black ink containing white colored granular powder, supplied as: NDC Number Size 0591-3984-01 bottle of 100 0591-3984-05 bottle of 500
CELECOXIB 400 mg capsules are opaque light green cap printed " WPI " with black ink and opaque white colored body printed " 400 " with black ink containing white colored granular powder, supplied as: NDC Number Size 0591-3985-60 bottle of 60 Storage Store at room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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