Country: Canada
Language: English
Source: Health Canada
ACETYLSALICYLIC ACID
VITA HEALTH PRODUCTS INC
B01AC06
ACETYLSALICYLIC ACID
81MG
TABLET (DELAYED-RELEASE)
ACETYLSALICYLIC ACID 81MG
ORAL
30/120/180/300
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169013; AHFS:
APPROVED
2011-02-17
ASA 81 mg Page 1 of 46 PRODUCT MONOGRAPH ASA 81 MG Acetylsalicylic Acid Delayed Release Tablets 81 mg USP Platelet aggregation inhibitor Vita Health Products Inc. 150 Beghin Avenue Winnipeg, MB Canada R2J 3W2 Control Number: 261087 Date of Preparation: February 3, 2011 Date of Revision : March 23, 2022 ASA 81 mg Page 2 of 46 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS .............................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................................. 4 ADVERSE REACTIONS ............................................................................................................... 7 DRUG INTERACTIONS ............................................................................................................... 7 DOSAGE AND ADMINISTRATION ........................................................................................... 9 OVERDOSAGE ........................................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 11 STORAGE AND STABILITY ..................................................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 13 PART II: SCIENTIFIC INFORMATION .............................................................................. 14 PHARMACEUTICAL INFORMATION ..................................................................................... 14 CLINICAL TRIALS .............. Read the complete document