celecoxib 400 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) ].
Mylan Pharmaceuticals Inc.
CAPSULE BLUE MYLAN 7170
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16 HOW SUPPLIED/STORAGE AND HANDLING Celecoxib capsules are available containing 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, USP. The 50 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and a light orange opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7165 in black ink on both the cap and the body. They are available as follows: NDC 0378-7165-91 bottles of 60 capsules The 100 mg capsules are hard-shell gelatin capsules with a Lavender opaque cap and a Lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7160 in black ink on both the cap and the body. They are available as follows: NDC 0378-7160-01 bottles of 100 capsules NDC 0378-7160-05 bottles of 500 capsules The 200 mg capsules are hard-shell gelatin capsules with a light blue opaque cap and a light blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7150 in black ink on both the cap and the body. They are available as follows: NDC 0378-7150-01 bottles of 100 capsules NDC 0378-7150-05 bottles of 500 capsules The 400 mg capsules are hard-shell gelatin capsules with a blue green opaque cap and a blue green opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7170 in black ink on both the cap and the body. They are available as follows: NDC 0378-7170-91 bottles of 60 capsules 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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