Country: Canada
Language: English
Source: Health Canada
ACETYLSALICYLIC ACID
PENDOPHARM DIVISION OF PHARMASCIENCE INC
N02BA01
ACETYLSALICYLIC ACID
325MG
TABLET (DELAYED-RELEASE)
ACETYLSALICYLIC ACID 325MG
ORAL
100
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169001; AHFS:
APPROVED
2002-03-08
PRODUCT MONOGRAPH ENTROPHEN ® 325 MG CAPLETS Acetylsalicylic Acid Delayed-release Tablets USP 325 mg ENTROPHEN ® 325 MG TABLETS Acetylsalicylic Acid Delayed-release Tablets USP 325 mg ENTROPHEN ® Acetylsalicylic Acid Delayed-release Tablets USP 81 mg ENTROPHEN ® CHEWABLE Acetylsalicylic Acid Tablets USP 81 mg Analgesic, anti-inflammatory, antipyretic and Platelet aggregation inhibitor PENDOPHARM, DIVISION OF PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Quebec H4P 2T4 DATE OF REVISION: November 16, 2021 www.pendopharm.com SUBMISSION CONTROL NUMBER: 255502 & 255545 ® Registered trademark of Pharmascience Inc. Page 2 of 45 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................3 INDICATIONS AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................5 WARNINGS AND PRECAUTIONS .............................................................................5 ADVERSE REACTIONS..............................................................................................8 DRUG INTERACTIONS ..............................................................................................8 DOSAGE AND ADMINISTRATION ......................................................................... 11 OVERDOSAGE ......................................................................................................... 12 ACTION AND CLINICAL PHARMACOLOGY......................................................... 13 STORAGE AND STABILITY .................................................................................... 14 SPECIAL HANDLING INSTRUCTIONS ................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 15 PART II : SCIENTIFIC INFOR Read the complete document