DALMACOL SYRUP

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

HYDROCODONE BITARTRATE; ETAFEDRIN HYDROCHLORIDE; SODIUM CITRATE; ALCOHOL ANHYDROUS; DOXYLAMINE SUCCINATE

Saatavilla:

LABORATOIRE RIVA INC.

ATC-koodi:

R05DA20

INN (Kansainvälinen yleisnimi):

COMBINATIONS

Annos:

1.65MG; 16.65MG; 200MG; 0.25ML; 6MG

Lääkemuoto:

SYRUP

Koostumus:

HYDROCODONE BITARTRATE 1.65MG; ETAFEDRIN HYDROCHLORIDE 16.65MG; SODIUM CITRATE 200MG; ALCOHOL ANHYDROUS 0.25ML; DOXYLAMINE SUCCINATE 6MG

Antoreitti:

ORAL

Kpl paketissa:

500ML/2L

Prescription tyyppi:

Narcotic (CDSA I)

Terapeuttinen alue:

ANTITUSSIVES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0514272001; AHFS:

Valtuutuksen tilan:

MARKETED

Valtuutus päivämäärä:

1997-03-26

Valmisteyhteenveto

DALMACOL
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DALMACOL
Hydrocodone Bitartrate,
Etafedrine Hydrochloride, Doxylamine Succinate,
Sodium Citrate and Alcohol Syrup
Hydrocodone bitartrate hemipentahydrate 0.33 mg/mL,
etafedrine hydrochloride 3.33 mg/mL,
doxylamine succinate 1.2 mg/mL,
sodium citrate dihydrate 40 mg/mL
and alcohol anhydrous 0.05 mL/mL
ANTITUSSIVE / ANTIHISTAMINIC / DECONGESTANT
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
Canada J7C 3V4
www.labriva.com
Date of Preparation:
September 23, 2020
Submission Control No: 243188
DALMACOL
Page 2 of 25
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
..............................................................................12
OVERDOSAGE
................................................................................................................13
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
................................................................................15
PHARMACEUTICAL INFORMATION
.............................................................