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:
Approved
Current status date:
2007-08-14
Product name:
ACETAMINOPHEN ELIXIR WITH 8MG CODEINE PHOSPHATE SYRUP
DIN:
02298708
Product Monograph/Veterinary Labelling:
Date:
2013-09-12
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JAMP PHARMA CORPORATION
1310 Rue Nobel
Boucherville
Quebec
Canada
J4B 5H3
Class:
Human
Dosage form(s):
Elixir
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08 , 28:08.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AJ06 CODEINE AND PARACETAMOL
Active ingredient group (AIG) number:See footnote5
0211376002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ACETAMINOPHEN | 160 MG / 5 ML |
| CODEINE PHOSPHATE | 8 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 |