The most common side effects of ULORIC include:

liver problems
nausea
gout flares
joint pain
rash
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ULORIC. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ULORIC?

Store ULORIC between 59°F - 86°F (15°C - 30°C).

Keep ULORIC out of the light.

Keep ULORIC and all medicines out of the reach of children.

General information about the safe and effective use of ULORIC

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use ULORIC for a condition for which it was not prescribed. Do not give ULORIC to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about ULORIC. If you would like more information about ULORIC talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ULORIC that is written for health professionals. For more information go to www.uloric.com, or call 1-877-825-3327.

What are the ingredients in ULORIC?

Active Ingredient: febuxostat

Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate, and Opadry II, green

Distributed by
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

U.S. Patent Nos. - 6,225,474; 7,361,676; 5,614,520.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.

All other trademark names are the property of their respective owners

©2009 Takeda Pharmaceuticals America, Inc.

PI1114 R1
February 2009

Repackaged by Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 80 mg 30 Tablet Bottle

30 Tablets
Rx only

Uloric®
febuxostat
tablets

80 mg

ULORIC
febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 21695-516(64764-677)
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
febuxostat(febuxostat) febuxostat 80mg
 
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 
cellulose, microcrystalline 
hydroxypropyl cellulose 
croscarmellose sodium 
silicon dioxide 
magnesium stearate 
 
Product Characteristics
Color GREEN (light green to green)  Score no score
Shape TEAR (teardrop shaped)  Size 14mm
Flavor  Imprint Code TAP;80 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 21695-516-30 30TABLETIn1BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 02/13/2009 

Labeler -Rebel Distributors Corp(118802834)
Establishment
Name Address ID/FEI