celecoxib 100 mg
1 INDICATIONS & USAGE Celecoxib capsules are indicated Celecoxib capsules are a non-steroidal 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 )] .
REMEDYREPACK INC.
CAPSULE BLUE C86 100
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB 100 mg capsules are white to off-white powder filled in size "3" hard gelatin capsule with blue opaque cap imprinted "C86" and white opaque body imprinted "l00", supplied as: NDC: 70518-4009-00 NDC: 70518-4009-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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