rea will cause a further lowering of blood glucose and may increase the risk of hypoglycemia due to the additive effects of the two agents. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.
HOW SUPPLIED
GLYSET Tablets are available as 25 mg, 50 mg, and 100 mg white, round, film-coated tablets. The tablets are debossed with the word "GLYSET" on one side and the strength on the other side, as indicated below.
Tablet
Identification
Strength NDC Front Back
Bottles of 100:
25 mg 0009-5012-01 GLYSET 25
50 mg 0009-5013-01 GLYSET 50
100 mg 0009-5014-01 GLYSET 100
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Manufactured by
Bayer HealthCare Pharmaceuticals Inc.
Made in Germany
GLYSET is a registered trademark of Bayer HealthCare Pharmaceuticals Inc. used under license.
LAB-0167-9.0
October 2010
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 0009-5012-01
100 Tablets
Rx only
Glyset®
miglitol tablets
25 mg
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC 0009-5013-01
100 Tablets
Rx only
Glyset®
miglitol tablets
50 mg
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC 0009-5014-01
100 Tablets
Rx only
Glyset®
miglitol tablets
100 mg
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
GLYSET
miglitol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-5012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
miglitol(miglitol) miglitol 25mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
magnesium stearate
hypromelloses
polyethylene glycol
titanium dioxide
polysorbate 80
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code GLYSET;25
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0009-5012-01 100TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020682 12/18/1996
GLYSET
miglitol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-5013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
miglitol(miglitol) miglitol 50mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
magnesium stearate
hypromelloses
polyethylene glycol
titanium dioxide
polysorbate 80
Product Characteristics
Color WHITE Score no score
Sh
