ADVIL COLD & SINUS PLUS 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:
15G/50G
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
_GlaxoSmithKline Consumer Healthcare Inc. _
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PRODUCT MONOGRAPH
ADVIL COLD & SINUS PLUS
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
200 mg/30 mg/2 mg
ADVIL COLD, SINUS & FLU EXTRA STRENGTH
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
400 mg/60 mg/4 mg
CHILDREN’S ADVIL
COLD & FLU MULTI-SYMPTOM
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Suspension
100 mg/15 mg/1 mg per 5 mL
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
April 3, 2020
Submission Control No.:237125
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................26
DOSAGE AND ADMINISTRATION
..............................................................................31
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................35
STORAGE AND STABILITY
..........................................................................................40
SPECIAL HANDLING INSTRUCTIONS
...........
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