celecoxib 50 mg
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) ].
aurobindo pharma limited
CAPSULE WHITE Z 50
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules, 50 mg are white cap/white body, size ‘5’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘50’ on the body with red ink. Bottles of 60 NDC 65862-907-60 Bottles of 1,000 NDC 65862-907-99
CELECOXIB capsules, 100 mg are white cap/white body, size ‘4’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘100’ on the body with blue ink. Bottles of 100 NDC 65862-908-01 Bottles of 500 NDC 65862-908-05 Bottles of 1,000 NDC 65862-908-99
CELECOXIB capsules, 200 mg are white cap/white body, size ‘2’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘200’ on the body with gold ink. Bottles of 100 NDC 65862-909-01 Bottles of 500 NDC 65862-909-05 Bottles of 1,000 NDC 65862-909-99
CELECOXIB capsules, 400 mg are white cap/white body, size ‘0’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘400’ on the body with green ink. Bottles of 60 NDC 65862-910-60 Bottles of 100 NDC 65862-910-01 Bottles of 500 NDC 65862-910-05 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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