celecoxib 100 mg
1 INDICATIONS AND USAGE Celecoxib is 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 ) Celecoxib capsules are indicated 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 ) ].
Cipla USA Inc.
CAPSULE WHITE Cipla 422 100 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules are available in the following strengths and configurations: Product Name Description Size NDC number
CELECOXIB capsules 50 mg white to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with 'Cipla' on cap & '423' over '50 mg' on body in red ink. Bottle of 30 capsules Bottle of 60 capsules 69097-423-02 69097-423-03
CELECOXIB capsules 100 mg white to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with 'Cipla' on cap & '422' over '100 mg' on body in blue ink. Bottle of 30 capsules Bottle of 100 capsules Bottle of 500 capsules 10's Blister Carton of 100 (10 x 10) Unit- dose capsules 69097-422-02 69097-422-07 69097-422-12 69097-422-19 69097-422-21
CELECOXIB capsules 200 mg white to off white colored granules filled in size 1 hard gelatin white capsule, axially printed with 'Cipla' on cap & '421' over '200 mg' on body in gold ink. Bottle of 30 capsules Bottle of 100 capsules Bottle of 500 capsules 10's Blister Carton of 100 (10 x 10) Unit- dose capsules 69097-421-02 69097-421-07 69097-421-12 69097-421-19 69097-421-21
CELECOXIB capsules 400 mg white to off white colored granules filled in size 0el hard gelatin white capsule, axially printed with 'Cipla' on cap & '420' over '400 mg' on body in green ink. Bottle of 30 capsules Bottle of 60 capsules Bottle of 480 capsules 10's Blister Carton of 100 (10 x 10) Unit- dose capsules 69097-420-02 69097-420-03 69097-420-11 69097-420-19 69097-420-21 Storage: Store at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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