ADVIL COLD AND SINUS NIGHTTIME TABLET

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:

200MG; 30MG; 2MG

Zāļu forma:

TABLET

Kompozīcija:

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

Ievadīšanas:

ORAL

Vienības iepakojumā:

6/10/12/20/40/72

Receptes veids:

OTC

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-12-08

Produkta apraksts

_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 1 of 67_
PRODUCT MONOGRAPH
ADVIL COLD & SINUS NIGHTTIME
Ibuprofen, Pseudoephedrine Hydrochloride
and Chlorpheniramine Maleate Caplets
200 mg/30 mg/2 mg
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
June 13, 2006
Revised: April 3, 2020
Submission Control No: 237320
_ _
_GlaxoSmithKline Consumer Healthcare Inc. _
_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35