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:

2022-05-16

Original market date: See footnote 1

2018-08-17

Product name:

ADVIL COLD, SINUS & FLU EXTRA STRENGTH

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:

02471604

Product Monograph/Veterinary Labelling:

Date: 2020-04-03 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):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

3

Schedule(s):

OTC

 

American Hospital Formulary Service (AHFS): See footnote 3

04:04.20  ,  28:08.04.92 

Anatomical Therapeutic Chemical (ATC): See footnote 4

M01AE51 IBUPROFEN, COMBINATIONS

Active ingredient group (AIG) number:See footnote5

0349765003

List of active ingredient(s)
Active ingredient(s) Strength
CHLORPHENIRAMINE MALEATE 4 MG
IBUPROFEN 400 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 60 MG
Version 4.0.2
Date modified: