CELEBREX celecoxib 200 MG Oral Capsule Celebrex
1. INDICATIONS AND USAGE CELEBREX is indicated CELEBREX 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) ].
G.D. Searle LLC Division of Pfizer Inc
CAPSULE WHITE 7767 200
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Aphena Pharma Solutions - Tennessee, LLC
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16. HOW SUPPLIED/STORAGE AND HANDLING CELEBREX (
CELECOXIB) 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as: NDC Number Size 0025-1515-01 bottle of 60 CELEBREX (
CELECOXIB) 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as: NDC Number Size 0025-1520-31 bottle of 100 0025-1520-51 bottle of 500 0025-1520-34 carton of 100 unit dose CELEBREX (
CELECOXIB) 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as: NDC Number Size 0025-1525-31 bottle of 100 0025-1525-51 bottle of 500 0025-1525-34 carton of 100 unit dose CELEBREX (
CELECOXIB) 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as: NDC Number Size 0025-1530-02 bottle of 60 0025-1530-01 carton of 100 unit dose 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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