ADVIL COLD & SINUS PLUS TABLET
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
03-04-2020
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Ingredient activ:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Disponibil de la:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
Codul ATC:
M01AE51
INN (nume internaţional):
IBUPROFEN, COMBINATIONS
Dozare:
200MG; 30MG; 2MG
Forma farmaceutică:
TABLET
Compoziție:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG
Calea de administrare:
ORAL
Unități în pachet:
15G/50G
Tip de prescriptie medicala:
OTC
Zonă Terapeutică:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Rezumat produs:
Active ingredient group (AIG) number: 0349765001; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2010-12-08
Caracteristicilor produsului
_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
...........
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