The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Advil Cold & Flu Coated TabletsIbuprofen 200mgPseudoephedrine Hydrochloride 30mg



Haleon Ireland LimitedPA0678/147/001

Main Information

Trade NameAdvil Cold & Flu Coated TabletsIbuprofen 200mgPseudoephedrine Hydrochloride 30mg
Active SubstancesIbuprofen
PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage FormCoated tablet
Licence HolderHaleon Ireland Limited
Licence NumberPA0678/147/001

Group Information

ATC CodeM01AE Propionic acid derivatives
M01AE51 ibuprofen, combinations

Status

License statusAuthorised
Licence Issued08/09/1994
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to the general public
Conditions of LicenceSale through pharmacies only in packs containing not more than 24 units per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. Not more than one pack of pseudoephedrine containing medicinal products should be supplied in the course of any one retail transaction unless a valid prescription exists. Ibuprofen- Subject to the following restrictions: maximum strength 200 mg, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children not under 12 years
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version
« Back