Celecoxib celecoxib 200 MG Oral Capsule
1 INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are 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 ) ].
Teva Pharmaceuticals USA Inc
CAPSULE YELLOW Teva 7166
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16 HOW SUPPLIED/STORAGE AND HANDLING Celecoxib capsules are available as follows: 50 mg - hard gelatin capsules with a white body and medium orange-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7306” on the body, in bottles of 60 (NDC 0093-7306-06). 100 mg - hard gelatin capsules with an opaque-white body and blue-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7165” on the body, in bottles of 100 (NDC 0093-7165-01) and 500 (0093-7165-05). 200 mg - hard gelatin capsules with an opaque-white body and yellow-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7166” on the body, in bottles of 100 (NDC 0093-7166-01) and 500 (NDC 0093-7166-05). 400 mg - hard gelatin capsules with a dark green body and cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7170” on the body, in bottles of 60 (NDC 0093-7170-06). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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