16 HOW SUPPLIED/STORAGE AND HANDLINGOSENI tablets are available in the following strengths and packages:

25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both "A/P" and "25/15" printed on one side, available in:

NDC 64764-251-03
 Bottles of 30 tablets
 
NDC 64764-251-04
 Bottles of 90 tablets
 
NDC 64764-251-05
 Bottles of 500 tablets
 

25 mg/30 mg tablet: peach, round, biconvex and film-coated with both "A/P" and "25/30" printed on one side, available in:

NDC 64764-253-03
 Bottles of 30 tablets
 
NDC 64764-253-04
 Bottles of 90 tablets
 
NDC 64764-253-05
 Bottles of 500 tablets
25 mg/45 mg tablet: red, round, biconvex, film-coated and with both "A/P" and "25/45" printed on one side, available in:

NDC 64764-254-03
 Bottles of 30 tablets
 
NDC 64764-254-04
 Bottles of 90 tablets
 
NDC 64764-254-05
 Bottles of 500 tablets
 

12.5 mg/15 mg tablet: pale yellow, round, biconvex and film-coated with both "A/P" and "12.5/15" printed on one side, available in:

NDC 64764-121-03
 Bottles of 30 tablets
 
NDC 64764-121-04
 Bottles of 90 tablets
 
NDC 64764-121-05
 Bottles of 500 tablets
 
12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both "A/P" and "12.5/30" printed on one side, available in:

NDC 64764-123-03
 Bottles of 30 tablets
 
NDC 64764-123-04
 Bottles of 90 tablets
 
NDC 64764-123-05
 Bottles of 500 tablets
 
12.5 mg/45 mg tablet: pale red, round, biconvex and film-coated with both "A/P" and "12.5/45" printed on one side, available in:

NDC 64764-124-03
 Bottles of 30 tablets
 
NDC 64764-124-04
 Bottles of 90 tablets
 
NDC 64764-124-05
 Bottles of 500 tablets
 
Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

17 PATIENT COUNSELING INFORMATIONSee FDA-Approved Patient Labeling (Medication Guide).

17.1 InstructionsInform patients of the potential risks and benefits of OSENI.

Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on OSENI should immediately report these symptoms to their physician.

Patients should be informed that acute pancreatitis has been reported during use of alogliptin. Patients should be informed that persistent, severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed t