ADVIL MIGRAINE EXTRA STRENGTH TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-08-2017
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Active ingredient:
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)
Available from:
PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC
ATC code:
M01AE01
INN (International Name):
IBUPROFEN
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG
Administration route:
ORAL
Units in package:
12/20/30/60/67/77/180
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0108883002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2018-08-02
Summary of Product characteristics
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
MIGRAINE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.
450 – 55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Submission Control No.: 206595
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.............................................
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