DIMETANE EXPECTORANT C SYRUP
Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
28-01-2021
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN
Disponibbli minn:
FOUNDATION CONSUMER BRANDS, LLC
Kodiċi ATC:
R05FA02
INN (Isem Internazzjonali):
OPIUM DERIVATIVES AND EXPECTORANTS
Dożaġġ:
1MG; 0.4MG; 2MG; 20MG
Għamla farmaċewtika:
SYRUP
Kompożizzjoni:
PHENYLEPHRINE HYDROCHLORIDE 1MG; BROMPHENIRAMINE MALEATE 0.4MG; CODEINE PHOSPHATE 2MG; GUAIFENESIN 20MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100ML/1000ML
Tip ta 'preskrizzjoni:
Narcotic (CDSA I)
Żona terapewtika:
ANTITUSSIVES
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0444284001; AHFS:
L-istatus ta 'awtorizzazzjoni:
CANCELLED POST MARKET
Data ta 'l-awtorizzazzjoni:
2021-12-31
Karatteristiċi tal-prodott
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
Aqra d-dokument sħiħ
