DIMETANE EXPECTORANT DC SYRUP

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; GUAIFENESIN; HYDROCODONE BITARTRATE

Tersedia dari:

FOUNDATION CONSUMER BRANDS, LLC

Kode ATC:

R05FA02

INN (Nama Internasional):

OPIUM DERIVATIVES AND EXPECTORANTS

Dosis:

5MG; 2MG; 100MG; 1.8MG

Bentuk farmasi:

SYRUP

Komposisi:

PHENYLEPHRINE HYDROCHLORIDE 5MG; BROMPHENIRAMINE MALEATE 2MG; GUAIFENESIN 100MG; HYDROCODONE BITARTRATE 1.8MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

ANTITUSSIVES

Ringkasan produk:

Active ingredient group (AIG) number: 0444285001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-12-31

Karakteristik produk

Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DIMETANE
®
EXPECTORANT DC
Brompheniramine Maleate, Phenylephrine Hydrochloride, Guaifenesin and
Hydrocodone
Bitartrate Syrup
2 mg/ 5 mg/ 100 mg/1.8 mg: per 5 mL of syrup
Antihistamine/ Decongestant/ Expectorant/ Antitussive
Foundation Consumer Brands LLC.
106 Isabella Street, Suite 602
Pittsburgh, PA
15212, USA
Date of Revision:
January 28, 2021
Distributed by:
Accuristix
100 Vaughan Valley Blvd.,
Vaughan, Ontario, Canada
L4H 3C5,
Submission Control No:
247426
Page 2 of 28
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
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
...........................................................................12
OVERDOSAGE
...............................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
............................