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:
2018-12-10
Original market date: See footnote 1
1970-12-31
Product name:
FIORINAL-C 1/2
DIN:
00176206
Product Monograph/Veterinary Labelling:
Date:
2023-07-18
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ARALEZ PHARMACEUTICALS CANADA INC
800
6733 Mississauga Rd
Mississauga
Ontario
Canada
L5N 6J5
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
4
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08 , 28:24.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AA79 CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
Active ingredient group (AIG) number:See footnote5
0401238001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ACETYLSALICYLIC ACID | 330 MG |
| BUTALBITAL | 50 MG |
| CAFFEINE | 40 MG |
| CODEINE PHOSPHATE | 30 MG |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |