Janumet 50 mg1000 mg Oral Tablet
1 INDICATIONS AND USAGE JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [See Clinical Studies (14) .] Important Limitations of Use JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2) .] JANUMET is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. ( 1 ) Important Limitations of Use: JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. ( 1 ) JANUMET has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ).
Physicians Total Care, Inc.
OVAL RED 577
577 OVAL RED
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with “575” debossed on one side. They are supplied as follows: NDC 54868-5973-0 unit-of-use bottles of 60. No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with “577” debossed on one side. They are supplied as follows: NDC 54868-1097-0 unit-of-use bottles of 60 NDC 54868-1097-1 unit-of-use bottles of 180. Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), [See USP Controlled Room Temperature]. Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., whitehouse Station, NJ 08889, USA 9984500 US Patent No.: 6,699,871 1,2 Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 3 GLUCOPHAGE ® is a registered trademark of Merck Sante S.A.S, an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company. Copyright © 2007, 2008, 2009, 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
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