CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

Pieejams no:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATĶ kods:

M01AE51

SNN (starptautisko nepatentēto nosaukumu):

IBUPROFEN, COMBINATIONS

Deva:

100MG; 15MG; 1MG

Zāļu forma:

SUSPENSION

Kompozīcija:

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

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/120ML

Receptes veids:

OTC

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-12-08

Produkta apraksts

_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. _
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_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
...........