celecoxib 200 mg
1. INDICATIONS AND USAGE Celecoxib capsule are indicated Celecoxib capsules are 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 For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis 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 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) ].
NIVAGEN PHARMACEUTICALS, INC.
CAPSULE WHITE CEL 200 mg
CEL 200 mg CAPSULE WHITE
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16. HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules 50 mg are white to white opaque hard gelatin capsules, imprinted with "CEL" on cap & "50 mg" on body in black ink supplied as: NDC Number Size 75834-236-60 bottle of 60 75834-236-11 carton of 100 unit dose 75834-236-05 bottle of 500
CELECOXIB capsules 100 mg are white to white opaque hard gelatin capsules, imprinted with "CEL" on cap & "100 mg" on body in black ink supplied as: NDC Number Size 75834-237-01 bottle of 100 75834-237-11 carton of 100 unit dose 75834-237-05 bottle of 500
CELECOXIB capsules 200 mg are white to white opaque hard gelatin capsules, imprinted with "CEL" on cap & "200 mg" on body in black ink supplied as: NDC Number Size 75834-238-01 bottle of 100 75834-238-11 carton of 100 unit dose 75834-238-05 bottle of 500
CELECOXIB capsules 400 mg are white to white opaque hard gelatin capsules, imprinted with "CEL" on cap & "400 mg" on body in black ink supplied as: NDC Number Size 75834-239-60 bottle of 60 75834-239-11 carton of 100 unit dose 75834-239-05 bottle of 500 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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