CELEBREX celecoxib 200 MG Oral Capsule Celebrex
1. INDICATIONS AND USAGE Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] 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) CELEBREX is indicated for relief of the signs and symptoms of OA [ see Clinical Studies (14.1) ] 1.2 Rheumatoid Arthritis (RA) CELEBREX is indicated for relief of the signs and symptoms of RA [ see Clinical Studies (14.2) ] 1.3 Juvenile Rheumatoid Arthritis (JRA) CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ] 1.4 Ankylosing Spondylitis (AS) CELEBREX is indicated for the relief of signs and symptoms of AS [ see Clinical Studies (14.4) ] 1.5 Acute Pain (AP) CELEBREX is indicated for the management of AP in adults [ see Clinical Studies (14.5) ] 1.6 Primary Dysmenorrhea (PD) CELEBREX is indicated for the treatment of PD [ see Clinical Studies (14.5) ]
Aphena Pharma Solutions - Tennessee, LLC
CAPSULE WHITE 7767 200
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16. HOW SUPPLIED/STORAGE AND HANDLING Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. CELEBREX 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 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 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 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
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