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 Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets



JNTL Consumer Health I (Ireland) LimitedPA23490/006/001

Main Information

Trade NameBENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets
Active SubstancesParacetamol
PSEUDOEPHEDRINE HYDROCHLORIDE
Paracetamol
Diphenhydramine hydrochloride
Dosage FormFilm-coated tablet
Licence HolderJNTL Consumer Health I (Ireland) Limited
Licence NumberPA23490/006/001

Group Information

ATC CodeN02BE51 paracetamol, combinations excl. psycholeptics

Status

License statusAuthorised
Licence Issued10/11/1988
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 16 units per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription.
Marketing StatusMarketed

Documents

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