Note: Ingredients listed on restricted chemical lists
EC/CAS
87-69-4
Name of the chemical
L-(+)-tartaric acid
Concentration
>=30-<50
EC/CAS
14807-96-6
Name of the chemical
Talc
Concentration
>=5-<10
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
>=1-<5
General Information
Version
3.0
Revision date
2024-01-30
Product name
Pradaxa Capsules
Product Synonyms
Pradaxa® Capsules 50 mg, 75 mg, 110 mg and 150 mg with active ingredient: Dabigatran Etexilate Mesilate
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user
supplier name
Boehringer Ingelheim Pharmaceuticals Inc
Emergency telephone
+1 703-527-3887, +1 703-741-5970
Icons in SDS
Company Information
company name
Boehringer Ingelheim Pharmaceuticals Inc
e-mail address of the competent person responsible for the Safety Data Sheet
EHS-Services@Boehringer-Ingelheim.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H318
Hazard statements
Code
Statements
H318
Causes serious eye damage
Section 2
SECTION 2: Hazards identification
Signal word
Danger
Hazard statements
H318 Causes serious eye damage.
Prevention
P280 Wear eye protection/ face protection.
Response
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.
2.3 Other hazards
This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet). This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.
2.1 Classification of the substance or mixture
1910.1200) Serious eye damage
