ADVIL COLD AND SINUS NIGHTTIME TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

Διαθέσιμο από:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Φαρμακολογική κατηγορία (ATC):

M01AE51

INN (Διεθνής Όνομα):

IBUPROFEN, COMBINATIONS

Δοσολογία:

200MG; 30MG; 2MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

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

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

6/10/12/20/40/72

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-12-08

Αρχείο Π.Χ.Π.

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_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
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_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