COLD + SINUS DAYTIME TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-10-2020
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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:
10/20/24/40/50/72/96/100
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0222394001; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-02-08
Summary of Product characteristics
PRODUCT MONOGRAPH
COLD + SINUS DAYTIME
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
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 19, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control # 239435
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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4
WARNINGS AND PRECAUTIONS
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5
ADVERSE REACTIONS
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13
DRUG INTERACTIONS
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23
DOSAGE AND ADMINISTRATION
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27
OVERDOSAGE
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28
ACTION AND CLINICAL PHARMACOLOGY
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31
STORAGE AND STABILITY
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36
SPECIAL HANDLING INSTRUCTIONS
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