celecoxib 100 mg
1. INDICATIONS AND USAGE Celecoxib is 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 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) ].
Micro Labs Limited
CAPSULE WHITE M 12
M 12 CAPSULE WHITE
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16. HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB 50 mg capsules are white opaque / white opaque, size ‘4’ hard gelatin capsule printed with ‘M’ on cap and ‘11’ on the body filled with white to off white granular powder, supplied as: NDC Number Size 42571-142-30 Bottles of 30 42571-142-60 Bottles of 60 42571-142-05 Bottles of 500 42571-142-33 Carton of 7x10 Unit-dose capsules
CELECOXIB 100 mg capsules are white opaque / white opaque, size ‘3’ hard gelatin capsule printed with ‘M’ on cap and ‘12’ on the body filled with white to off white granular powder, supplied as: NDC Number Size 42571-143-30 Bottles of 30 42571-143-60 Bottles of 60 42571-143-01 Bottles of 100 42571-143-05 Bottles of 500 42571-143-33 Carton of 7x10 Unit-dose capsules
CELECOXIB 200 mg capsules are white opaque / white opaque, size ‘1’ hard gelatin capsule printed with ‘M’ on cap and ‘13’ on the body filled with white to off white granular powder, supplied as: NDC Number Size 42571-144-30 Bottles of 30 42571-144-60 Bottles of 60 42571-144-01 Bottles of 100 42571-144-05 Bottles of 500 42571-144-29 Carton of 6x10 Unit-dose capsules
CELECOXIB 400 mg capsules are white opaque / white opaque, size ‘00’ hard gelatin capsule printed with ‘M’ on cap and ‘14’ on the body filled with white to off white granular powder, supplied as: NDC Number Size 42571-145-60 Bottles of 60 42571-145-05 Bottles 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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