ADVIL COLD & SINUS PLUS TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
03-04-2020

Aktiv ingrediens:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

Tilgjengelig fra:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC-kode:

M01AE51

INN (International Name):

IBUPROFEN, COMBINATIONS

Dosering :

200MG; 30MG; 2MG

Legemiddelform:

TABLET

Sammensetning:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

OTC

Terapeutisk område:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0349765001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-12-08

Preparatomtale

                                _GlaxoSmithKline Consumer Healthcare Inc. _
_ _
_Page 1_
_ of 86_
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. _
_ _
_Page 2_
_ of 86_
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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