Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg
- Licence status
- Active substances
- Paracetamol, PSEUDOEPHEDRINE HYDROCHLORIDE, Diphenhydramine hydrochloride
- Dosage Form
- Film-coated tablet
- Licence number
- PA23490/013/001
- Licence holder
- JNTL Consumer Health (Ireland) Limited
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- N02BE Anilides, N02BE51 paracetamol, combinations excl. psycholeptics
- Legal supply status
- Product not subject to medical prescription
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Sale 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 availability
- Marketed
- Advertising conditions
- Advertising to the general public
- Licence issued
- 02/06/1998