Diclofenac sodium and Misoprostol Diclofenac Sodium 75 MG Misoprostol 0.2 MG Oral Tablet
1 INDICATIONS AND USAGE Diclofenac sodium/misoprostol is 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/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) 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 )
Greenstone LLC
ROUND WHITE 75 G 0029
75 G 0029 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
DICLOFENAC SODIUM AND MISOPROSTOL delayed-release tablets are supplied as: • 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with a "50" in the middle on one side and "G" and "0028" on the other. • 75 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with a "75" in the middle on one side and "G" and "0029" on the other. The dosage strengths are supplied in: Strength NDC Number Size Diclofenac sodium/misoprostol 50 50 mg diclofenac sodium and 200 mcg misoprostol 59762-0028-1 bottle of 60 59762-0028-2 bottle of 90 Diclofenac sodium/misoprostol 75 75 mg diclofenac sodium and 200 mcg misoprostol 59762-0029-1 bottle of 60 Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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