Approval · Notice of Compliance 34665 · 2025
ADVIL COLD & SINUS PLUS: Notice of Compliance 34665
Issued January 10, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 34665
- Date
- January 10, 2025
- Company
- Glaxosmithkline Consumer Healthcare UlcMississauga, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety information. Product Monograph reformatted to the Master Template. Update to package insert. Update to package labels.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVIL COLD & SINUS PLUS | Not yet assigned | — |
| ADVIL COLD AND SINUS NIGHTTIME | Not yet assigned | — |
| ADVIL COLD, SINUS & FLU EXTRA STRENGTH | Not yet assigned | — |
| CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM | Not yet assigned | — |
Medicinal ingredients
- CHLORPHENIRAMINE MALEATE 2 MG per TAB
- IBUPROFEN 200 MG per TAB
- PSEUDOEPHEDRINE HCL 30 MG per TAB
- CHLORPHENIRAMINE MALEATE 4 MG per TAB
- IBUPROFEN 400 MG per TAB
- PSEUDOEPHEDRINE HCL 60 MG per TAB
- CHLORPHENIRAMINE MALEATE 1 MG per 5ML
- IBUPROFEN 100 MG per 5ML
- PSEUDOEPHEDRINE HCL 15 MG per 5ML