ay, or start later in therapy. You may need a lower dose or need to stop taking GLUMETZA.
These are not all the side effects with GLUMETZA. For more information, ask your doctor or pharmacist.
How should I store GLUMETZA?
Store GLUMETZA at room temperature, 59° to 86°F (15° to 30°C).
Keep GLUMETZA and all medicines out of the reach of children.
General information about GLUMETZA.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use GLUMETZA for a condition for which it was not prescribed. Do not give GLUMETZA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about GLUMETZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about GLUMETZA that is written for health professionals or contact 1-866-458-6389.
What are the ingredients in GLUMETZA?
Active Ingredient: 500mg or 1000mg of metformin HCl
Inactive Ingredient: Each 500mg tablet contains coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide. Each 1000mg tablet contains colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl behenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, titanium dioxide, simethicone emulsion, polysorbate and coloring. GLUMETZA 500mg and 1000mg tablets both utilize advanced, polymer-based, oral drug delivery systems, which allow delivery of metformin HCl to the upper GI tract.
Rx Only
Depomed, Inc.
Menlo Park, CA
(866) 458-6389
©2008 Depomed, Inc.
www.GlumetzaXR.com
PRINCIPAL DISPLAY PANEL
GLUMETZA tablets 500mg
GLUMETZA
metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-0830(13913-002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(METFORMIN) METFORMIN HYDROCHLORIDE 500mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
Product Characteristics
Color blue (Blue) Score no score
Shape OVAL (Oval) Size 18mm
Flavor Imprint Code GMZ;500
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 54868-0830-0 10TABLETIn1BOTTLE, PLASTIC None
2 54868-0830-1 30TABLETIn1BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021748 03/26/2007
Labeler -Physicians Total Care, Inc.(194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel,repack
