Diclofenac Sodium 75 MG Misoprostol 0.2 MG Delayed Release Oral Tablet
1 INDICATIONS AND USAGE Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2) ]. Diclofenac sodium and misoprostol delayed-release tablets are a combination non-steroidal anti-inflammatory and prostaglandin E 1 analog drug indicated for the treatment of signs and symptoms of osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications ( 1 )
avkare, inc.
ROUND WHITE 0398
0398 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
DICLOFENAC SODIUM AND MISOPROSTOL delayed-release tablets, USP are supplied in dosage strengths of either 50 mg diclofenac sodium/0.2 mg misoprostol or 75 mg diclofenac sodium/0.2 mg misoprostol. The 50 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0397 ” on the other side. The 75 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0398 ” on the other side. The dosage strengths are supplied in: Strength NDC Number Size 50 mg /0.2 mg 42291-232-60 bottle of 60 50 mg /0.2 mg 42291-232-90 bottle of 90 75 mg /0.2 mg 42291-233-60 bottle of 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature], in a dry area.
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