Metformin hydrochloride 500 MG sitagliptin 50 MG Oral Tablet Janumet
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. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. 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 combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUMET should not be used in patients with type 1 diabetes. ( 1 ) JANUMET has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 )
Merck Sharp & Dohme Corp.
OVAL PINK 575
575 OVAL PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets supplied as follows: Contents Description How Supplied NDC 50 mg sitagliptin and 500 mg metformin HCl light pink, capsule-shaped, film-coated tablets with “575” debossed on one side unit-of-use bottles of 60 NDC 0006-0575-61 unit-of-use bottles of 180 NDC 0006-0575-62 bulk bottles of 1000 NDC 0006-0575-82 50 mg sitagliptin and 1000 mg metformin HCl red, capsule-shaped, film-coated tablets with “577” debossed on one side unit-of-use bottles of 60 NDC 0006-0577-61 unit-of-use bottles of 180 NDC 0006-0577-62 bulk bottles of 1000 NDC 0006-0577-82 Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
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