ADVIL COLD AND SINUS NIGHTTIME TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-04-2020
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Active ingredient:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Available from:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC code:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
Dosage:
200MG; 30MG; 2MG
Pharmaceutical form:
TABLET
Composition:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG
Administration route:
ORAL
Units in package:
6/10/12/20/40/72
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0349765001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-12-08
Summary of Product characteristics
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_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 67_
PRODUCT MONOGRAPH
ADVIL COLD & SINUS NIGHTTIME
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
200 mg/30 mg/2 mg
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
June 13, 2006
Revised: April 3, 2020
Submission Control No: 237320
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_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
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