COLD + SINUS CAPLETS TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-02-2012
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Active ingredient:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Available from:
VITA HEALTH PRODUCTS INC
ATC code:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
Dosage:
200MG; 30MG
Pharmaceutical form:
TABLET
Composition:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
Administration route:
ORAL
Units in package:
10/20
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0222394001; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-10-17
Summary of Product characteristics
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_Page 1 of 50_
PRODUCT MONOGRAPH
COLD + SINUS CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
USP
Analgesic/Antipyretic/Nasal Decongestant
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, Manitoba
Canada, R2J 3W2
Control No. 151199
Date of Revision:
January 30, 2012
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_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
...............................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND
STABILITY..........................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL
INFORMATION..........................................................................29
CLINICAL
TRIALS..........................................................................................................31
DETAILED
PHARMACOLOGY.....................................................................................33
TOXICOLOGY
.......
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