Страна: Канада
мова: англійська
Джерело: Health Canada
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; GUAIFENESIN; HYDROCODONE BITARTRATE
FOUNDATION CONSUMER BRANDS, LLC
R05FA02
OPIUM DERIVATIVES AND EXPECTORANTS
5MG; 2MG; 100MG; 1.8MG
SYRUP
PHENYLEPHRINE HYDROCHLORIDE 5MG; BROMPHENIRAMINE MALEATE 2MG; GUAIFENESIN 100MG; HYDROCODONE BITARTRATE 1.8MG
ORAL
100
Narcotic (CDSA I)
ANTITUSSIVES
Active ingredient group (AIG) number: 0444285001; AHFS:
CANCELLED POST MARKET
2021-12-31
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 ............................ Прочитайте повний документ