CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM SUSPENSION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

MAH:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC_code:

M01AE51

INN:

IBUPROFEN, COMBINATIONS

dosage:

100MG; 15MG; 1MG

pharmaceutical_form:

SUSPENSION

composition:

IBUPROFEN 100MG; PSEUDOEPHEDRINE HYDROCHLORIDE 15MG; CHLORPHENIRAMINE MALEATE 1MG

administration_route:

ORAL

units_in_package:

100/120ML

prescription_type:

OTC

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0349765002; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-12-08

SPC

_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
_GlaxoSmithKline Consumer Healthcare Inc. _
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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
...........