For more information, go to www.PRADAXA.com or call 1-800-542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in PRADAXA?

Active ingredient: dabigatran etexilate mesylate

Inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Revised: March 2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Copyright 2011 Boehringer Ingelheim Pharmaceuticals, Inc.
ALL RIGHTS RESERVED

75461-02
IT5060BC072011

75457-02
IT5400B

Repackaged by

Rebel Distributors Corp

Thousand Oaks, CA 91320

Coumadin® is a registered trademark for Bristol-Myers Squibb
Jantoven® is a registered trademark for USL Pharma
Plavix® is a registered trademark of sanofi aventis
Effient® is a registered trademark of Eli Lilly and Company
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PRADAXA
dabigatran etexilate mesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 21695-899(0597-0135)
Route of Administration ORAL DEA Schedule 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dabigatran etexilate mesylate(dabigatran etexilate) dabigatran etexilate 150mg
Inactive Ingredients
Ingredient Name Strength
ACACIA 
DIMETHICONE 
HYPROMELLOSES 
HYDROXYPROPYL CELLULOSE 
TALC 
TARTARIC ACID 
CARRAGEENAN 
FD&C BLUE NO. 2 
FD&C YELLOW NO. 6 
POTASSIUM CHLORIDE 
TITANIUM DIOXIDE 
SHELLAC 
ALCOHOL 
METHYL ALCOHOL 
BUTYL ALCOHOL 
ISOPROPYL ALCOHOL 
FERROSOFERRIC OXIDE 
WATER 
PROPYLENE GLYCOL 
Product Characteristics
Color BLUE (Light Blue) ,WHITE (Cream colored)  Score no score
Shape CAPSULE Size 22mm
Flavor  Imprint Code R150; 
Contains 
Packaging
# NDC Package Description Multilevel Packaging
1 21695-899-60 60CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022512 10/26/2010 

Labeler -Rebel Distributors Corp(118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp  118802834 RELABEL,REPACK