DIMETANE EXPECTORANT C SYRUP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-01-2021
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Active ingredient:
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN
Available from:
FOUNDATION CONSUMER BRANDS, LLC
ATC code:
R05FA02
INN (International Name):
OPIUM DERIVATIVES AND EXPECTORANTS
Dosage:
1MG; 0.4MG; 2MG; 20MG
Pharmaceutical form:
SYRUP
Composition:
PHENYLEPHRINE HYDROCHLORIDE 1MG; BROMPHENIRAMINE MALEATE 0.4MG; CODEINE PHOSPHATE 2MG; GUAIFENESIN 20MG
Administration route:
ORAL
Units in package:
100ML/1000ML
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
ANTITUSSIVES
Product summary:
Active ingredient group (AIG) number: 0444284001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-12-31
Summary of Product characteristics
Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DIMETANE
®
EXPECTORANT C
Brompheniramine Maleate, Phenylephrine Hydrochloride, Guaifenesin and
Codeine Phosphate
Syrup
0.4 mg / 1 mg / 20 mg / 2 mg: per mL of syrup
Antihistamine/Decongestant/Expectorant/Antitussive
Foundation Consumer Brands LLC
Pittsburgh, PA 15212, USA
Date of Revision:
January 28, 2021
Distributed by: Accuristix., Vaughan, ON L4H 3C5.
Submission Control No:
247367
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
...........................................................................13
OVERDOSAGE
...............................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
PART III: CONSUMER MEDICATION INFORMATIO
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