DIMETANE EXPECTORANT C SYRUP

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN

Dostopno od:

FOUNDATION CONSUMER BRANDS, LLC

Koda artikla:

R05FA02

INN (mednarodno ime):

OPIUM DERIVATIVES AND EXPECTORANTS

Odmerek:

1MG; 0.4MG; 2MG; 20MG

Farmacevtska oblika:

SYRUP

Sestava:

PHENYLEPHRINE HYDROCHLORIDE 1MG; BROMPHENIRAMINE MALEATE 0.4MG; CODEINE PHOSPHATE 2MG; GUAIFENESIN 20MG

Pot uporabe:

ORAL

Enote v paketu:

100ML/1000ML

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

ANTITUSSIVES

Povzetek izdelek:

Active ingredient group (AIG) number: 0444284001; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2021-12-31

Lastnosti izdelka

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