DIMETANE EXPECTORANT C SYRUP
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-01-2021
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN
Fáanlegur frá:
FOUNDATION CONSUMER BRANDS, LLC
ATC númer:
R05FA02
INN (Alþjóðlegt nafn):
OPIUM DERIVATIVES AND EXPECTORANTS
Skammtar:
1MG; 0.4MG; 2MG; 20MG
Lyfjaform:
SYRUP
Samsetning:
PHENYLEPHRINE HYDROCHLORIDE 1MG; BROMPHENIRAMINE MALEATE 0.4MG; CODEINE PHOSPHATE 2MG; GUAIFENESIN 20MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100ML/1000ML
Gerð lyfseðils:
Narcotic (CDSA I)
Lækningarsvæði:
ANTITUSSIVES
Vörulýsing:
Active ingredient group (AIG) number: 0444284001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2021-12-31
Vara einkenni
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
Lestu allt skjalið
