COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME KIT

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

MAH:

VITA HEALTH PRODUCTS INC

ATC_code:

M01AE51

INN:

IBUPROFEN, COMBINATIONS

dosage:

200MG; 30MG; 200MG; 30MG; 2MG

pharmaceutical_form:

KIT

composition:

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

administration_route:

ORAL

units_in_package:

12+6

prescription_type:

OTC

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0553187001; AHFS:

authorization_status:

APPROVED

authorization_date:

2011-11-04

SPC

Page 1 of 66
PRODUCT MONOGRAPH
COLD + SINUS NIGHTTIME
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
and Chlorpheniramine Maleate 2 mg
Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
October 31, 2011
Winnipeg, Manitoba Canada, R2J 3W2
Control# 149333
Page 2 of 66
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
................................................................................................
12
DRUG INTERACTIONS
................................................................................................
20
DOSAGE AND ADMINISTRATION
............................................................................
24
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
........................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
......................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
................................................................................
34
PHARMACEUTICAL INFORMATION
........................................................................
34
CLINICAL TRIALS
.......................................