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:
Cancelled Post Market
Current status date:
2023-09-14
Original market date: See footnote 1
1993-12-31
Lot number: See footnote 2
EW4244
Expiry date: See footnote 2
2023-05-31
Product name:
ROBITUSSIN AC
DIN:
01934740
Product Monograph/Veterinary Labelling:
Date:
2020-10-08
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
450
55 Standish Court
Mississauga
Ontario
Canada
L5R 4B2
Class:
Human
Dosage form(s):
Syrup
Route(s) of administration:
Oral
Number of active ingredient(s):
3
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
48:08.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
R05FA02 OPIUM DERIVATIVES AND EXPECTORANTS
Active ingredient group (AIG) number:See footnote5
0303191001
Active ingredient(s) | Strength |
---|---|
CODEINE PHOSPHATE | 10 MG / 5 ML |
GUAIFENESIN | 100 MG / 5 ML |
PHENIRAMINE MALEATE | 7.5 MG / 5 ML |
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 |