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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:

2020-10-21

Original market date: See footnote 1

1970-12-31

Product name:

FIORINAL-C 1/4

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

00176192

Product Monograph/Veterinary Labelling:

Date: 2018-07-16 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)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS ,  28:24.04   BARBITURATES

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AA79  CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Active ingredient group (AIG) number:See footnote 5

0401238002

List of active ingredient(s)
Active ingredient(s) Strength
ACETYLSALICYLIC ACID 330 MG
BUTALBITAL 50 MG
CAFFEINE 40 MG
CODEINE PHOSPHATE 15 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

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