celecoxib 50 MG Oral Capsule
1 INDICATIONS AND USAGE Celecoxib capsules are indicated 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) ].
apotex corp.
CAPSULE WHITE APo C50
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celecoxib 200 MG Oral Capsule
Apotex Corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules 50 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C50” is imprinted on each capsule in red ink. They are supplied as follows: Bottles of 30s NDC 60505-3847-3 Bottles of 60s NDC 60505-3847-6 Bottles of 100s NDC 60505-3847-1 Bottles of 1,000 NDC 60505-3847-8
CELECOXIB capsules 100 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C100” is imprinted on each capsule in blue ink. They are supplied as follows: Bottles of 30s NDC 60505-3848-3 Bottles of 100s NDC 60505-3848-1 Bottles of 500s NDC 60505-3848-5 Bottles of 1,000 NDC 60505-3848-8
CELECOXIB capsules 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C200” is imprinted on each capsule in yellow ink. They are supplied as follows: Bottles of 30s NDC 60505-3849-3 Bottles of 100s NDC 60505-3849-1 Bottles of 500s NDC 60505-3849-5 Bottles of 1,000 NDC 60505-3849-8 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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