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 adult 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 (5.3) ] . Diclofenac sodium and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PG E1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. ( 1 )
Amneal Pharmaceuticals LLC
ROUND WHITE AN 438
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Amneal Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as a tablet in dosage strengths of either 50 mg diclofenac sodium, USP/200 mcg misoprostol, USP or 75 mg diclofenac sodium, USP/200 mcg misoprostol, USP. The 50 mg/200 mcg dosage strength is supplied as white to off-white, round shaped, biconvex tablets debossed with “AN” on one side and “436” on the other side. They are available as follows: Bottles of 30: NDC 65162-436-03 Bottles of 60 NDC 65162-436-06 Bottles of 90 NDC 65162-436-09 Bottles of 100: NDC 65162-436-10 The 75 mg/200 mcg dosage strength is supplied as white to off-white, round shaped, biconvex tablets debossed with “AN” on one side and “438” on the other side. They are available as follows: Bottles of 30: NDC 65162-438-03 Bottles of 60: NDC 65162-438-06 Bottles of 100: NDC 65162-438-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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