ADVIL COLD AND SINUS NIGHTTIME TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

זמין מ:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

קוד ATC:

M01AE51

INN (שם בינלאומי):

IBUPROFEN, COMBINATIONS

כמות:

200MG; 30MG; 2MG

טופס פרצבטיות:

TABLET

הרכב:

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

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

6/10/12/20/40/72

סוג מרשם:

OTC

איזור תרפויטי:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2010-12-08

מאפייני מוצר

_ _
_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