ASA 81 MG TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-03-2022
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Active ingredient:
ACETYLSALICYLIC ACID
Available from:
VITA HEALTH PRODUCTS INC
ATC code:
B01AC06
INN (International Name):
ACETYLSALICYLIC ACID
Dosage:
81MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ACETYLSALICYLIC ACID 81MG
Administration route:
ORAL
Units in package:
30/120/180/300
Prescription type:
OTC
Therapeutic area:
SALICYLATES
Product summary:
Active ingredient group (AIG) number: 0101169013; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-09-23
Summary of Product characteristics
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
..............
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