or medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-526-7736.
How should I store INVOKANA?
◦Store INVOKANA at room temperature between 68°F to 77°F (20°C to 25°C).
◦Keep INVOKANA and all medicines out of the reach of children.
General information about the safe and effective use of INVOKANA.
Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use INVOKANA for a condition for which it was not prescribed. Do not give INVOKANA to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about INVOKANA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INVOKANA that is written for healthcare professionals.
For more information about INVOKANA, call 1-800-526-7736 or visit our website at www.invokana.com.
What are the ingredients of INVOKANA?
Active ingredient: canagliflozin
Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. In addition, the tablet coating contains iron oxide yellow E172 (100 mg tablet only), macrogol/PEG, polyvinyl alcohol, talc, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Active ingredient made in Belgium.
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778
Licensed from Mitsubishi Tanabe Pharma Corporation
Date of approval: March 2013
© 2013 Janssen Pharmaceuticals, Inc.
1 The brands listed are trademarks of their respective owners and are not trademarks of Janssen Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL -- 100 mg Bottle Label
NDC 50458-140- 30
30 tablets
Invokana ™
(canagliflozin)
Tablets 100 mg
Dispense with Medication Guide
JanssenRx only
(click image for full-size original) PRINCIPAL DISPLAY PANEL -- 300 mg Bottle Label
NDC 50458-141- 30
30 tablets
Invokana ™
(canagliflozin)
Tablets 300 mg
Dispense with Medication Guide
JanssenRx only
INVOKANA canagliflozin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
canagliflozin (canagliflozin anhydrous) canagliflozin anhydrous 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (TYPE H)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 11mm
Flavor Imprint Code CFZ;100
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:50458-140-30 30 TABLET, FI |
