COLD + SINUS PLUS TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-09-2020
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Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; CHLORPHENIRAMINE MALEATE
Available from:
VITA HEALTH PRODUCTS INC
ATC code:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
Dosage:
30.0MG; 200.0MG; 2.0MG
Pharmaceutical form:
TABLET
Composition:
PSEUDOEPHEDRINE HYDROCHLORIDE 30.0MG; IBUPROFEN 200.0MG; CHLORPHENIRAMINE MALEATE 2.0MG
Administration route:
ORAL
Units in package:
10/20/24/72/100
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0349765001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-11-29
Summary of Product characteristics
Page 1 of 69
PRODUCT MONOGRAPH
COLD + SINUS PLUS
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
September 16, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control No.: 238538
Page 2 of 69
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
................................................................................................
21
DOSAGE AND ADMINISTRATION
............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
........................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
......................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 35
PART II: SCIENTIFIC INFORMATION
................................................................................
36
PHARMACEUTICAL INFORMATION
........................................................................
36
CLINICAL TRIALS
........................................
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