My HPRA: Register

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


Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg



JNTL Consumer Health I (Ireland) LimitedPA23490/013/001

Main Information

Trade NameBenylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg
Active SubstancesParacetamol
PSEUDOEPHEDRINE HYDROCHLORIDE
Diphenhydramine hydrochloride
Dosage FormFilm-coated tablet
Licence HolderJNTL Consumer Health I (Ireland) Limited
Licence NumberPA23490/013/001

Group Information

ATC CodeN02BE Anilides
N02BE51 paracetamol, combinations excl. psycholeptics

Status

License statusAuthorised
Licence Issued02/06/1998
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. Warnings Do not exceed stated dose. May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema or if accompanied by excessive phlegm, unless directed by a doctor. a) The statement “CONTAINS PARACETAMOL” should be clearly carried in contrasting boxed bold type on the package together with the following warning: “DO NOT TAKE ANY OTHER PARACETAMOL CONTAINING PRODUCTS”. b) The package label should also contain the following precaution “IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN THE EVENT OF OVERDOSAGE EVEN IF YOU FEEL WELL. PLEASE READ THE ENCLOSED LEAFLET CAREFULLY”. The package leaflet should contain the following statement, (over word restriction)
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back
Follow medicine

Print