ADVIL LIQUI-GELS CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-05-2020
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Active ingredient:
IBUPROFEN
Available from:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC code:
M01AE01
INN (International Name):
IBUPROFEN
Dosage:
200MG
Pharmaceutical form:
CAPSULE
Composition:
IBUPROFEN 200MG
Administration route:
ORAL
Units in package:
2/4/8/12/16/24/32/72/84/115/120/165/180
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0108883004; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-03-01
Summary of Product characteristics
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_GlaxoSmithKline Consumer Healthcare Inc. Page 1 of 45_
PRODUCT MONOGRAPH
ADVIL
®
LIQUI-GELS
Ibuprofen Capsules 200 mg (free acid and potassium salt)
ADVIL
® EXTRA STRENGTH LIQUI-GELS
Ibuprofen Capsules 400 mg (free acid and potassium salt)
ADVIL
® ARTHRITIS PAIN
Ibuprofen Capsules 400 mg (free acid and potassium salt)
Analgesic/Antipyretic
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
February 26, 2004
Date of Revision :
May 7, 2020
Submission Control No: 238543
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_GlaxoSmithKline Consumer Healthcare Inc Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTI
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