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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 (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) ].

Alembic Pharmaceuticals Inc.


2 years ago CAPSULE WHITE A 135 celecoxib 100 mg

CAPSULE WHITE A 135

16 HOW SUPPLIED/STORAGE AND HANDLING

CELECOXIB capsules 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder. NDC 62332-140-30 bottle of 30 capsules NDC 62332-140-60 bottle of 60 capsules NDC 62332-140-91 bottle of 1000 capsules NDC 62332-140-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-140-10 carton of 100 (10 x 10) unit-dose capsules

CELECOXIB capsules 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder. NDC 62332-141-30 bottle of 30 capsules NDC 62332-141-60 bottle of 60 capsules NDC 62332-141-31 bottle of 100 capsules NDC 62332-141-71 bottle of 500 capsules NDC 62332-141-91 bottle of 1000 capsules NDC 62332-141-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-141-10 carton of 100 (10 x 10) unit-dose capsules

CELECOXIB capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder. NDC 62332-142-30 bottle of 30 capsules NDC 62332-142-60 bottle of 60 capsules NDC 62332-142-31 bottle of 100 capsules NDC 62332-142-71 bottle of 500 capsules NDC 62332-142-91 bottle of 1000 capsules NDC 62332-142-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-142-10 carton of 100 (10 x 10) unit-dose capsules

CELECOXIB capsules 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder. NDC 62332-143-30 bottle of 30 capsules NDC 62332-143-60 bottle of 60 capsules NDC 62332-143-71 bottle of 500 capsules NDC 62332-143-10 carton of 100 (10 x 10) unit-dose capsules NDC 62332-143-14 carton of 126 (9 x 14) unit-dose capsules Storage : Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].


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