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


Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension



Johnson & Johnson (Ireland) LimitedPA0330/017/004

Main Information

Trade NameCalpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension
Active SubstancesParacetamol
Dosage FormOral suspension
Licence HolderJohnson & Johnson (Ireland) Limited
Licence NumberPA0330/017/004

Group Information

ATC CodeN02BE Anilides
N02BE01 paracetamol

Status

License statusAuthorised
Licence Issued22/03/1993
Legal statusProduct not subject to medical prescription
Supply StatusSupply through non-pharmacy outlets and pharmacies
Advertising StatusAdvertising to the general public
Conditions of LicenceGeneral sale in child resistant packs containing not more than 60ml of the 120mg/5ml unit dosage form. Only one pack should be supplied in the course of any one retail transaction. Retail sale through pharmacies only in child resistant packs containing not more than 140 ml of the120mg/5ml unit dosage form. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Promotion to the general public for packs containing not more than 140 ml of the 120mg/5ml unit dose.
Marketing StatusMarketed

Documents

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

Print