Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
1997-03-26
Original market date: See footnote 1
1997-03-26
Product name:
DALMACOL
DIN:
02230769
Product Monograph/Veterinary Labelling:
Date:
2020-09-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville
Quebec
Canada
J7C 3V4
Class:
Human
Dosage form(s):
Syrup
Route(s) of administration:
Oral
Number of active ingredient(s):
5
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
48:08.00 , 04:04.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
R05DA20 COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0514272001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ALCOHOL ANHYDROUS | 0.25 ML / 5 ML |
| DOXYLAMINE SUCCINATE | 6 MG / 5 ML |
| ETAFEDRIN HYDROCHLORIDE | 16.65 MG / 5 ML |
| HYDROCODONE BITARTRATE | 1.65 MG / 5 ML |
| SODIUM CITRATE | 200 MG / 5 ML |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.