Famotidine 26.6 MG Ibuprofen 800 MG Oral Tablet Duexis
1 INDICATIONS AND USAGE DUEXIS, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14) , Use in Specific Populations (8.5) ] . DUEXIS, a combination of a nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. ( 1 )
Horizon Pharma Inc.
OVAL BLUE HZT
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Famotidine 26.6 MG Ibuprofen 800 MG Oral Tablet Duexis
Horizon Pharma Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING DUEXIS (
IBUPROFEN AND FAMOTIDINE) tablets, 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with "HZT" on one side and supplied as: NDC Number Size 75987-010-03 Bottle of 90 tablets Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]
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