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Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg capsules, hard



Chefaro Ireland DACPA1186/025/001

Main Information

Trade NameParacetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg capsules, hard
Active SubstancesParacetamol
Guaifenesin
Phenylephrine hydrochloride
Dosage FormCapsule, hard
Licence HolderChefaro Ireland DAC
Licence NumberPA1186/025/001

Group Information

ATC CodeN02BE51 paracetamol, combinations excl. psycholeptics

Status

License statusAuthorised
Licence Issued10/09/2021
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to the general public
Conditions of LicencePharmacy only: MAXIMUM PACK SIZE 24. Maximum two packs per sale. Promotion to the public. Prescription only: Pack size greater than 24; Promotion to healthcare professionals. Paracetamol Retail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Packs containing more than 24 unit dosage forms may be supplied to pharmacies for the use by pharmacists provided the label states that they are for dispensing purposes only. Packs containing more than 50 unit dosage forms are prescription only. Promotion to the public subject to the following restrictions for phenylephrine base: maximum dose 12.2mg, maximum daily dose 48.8mg. Paracetamol Promotion to the general public for packs containing not more than 24 unit dosage forms Promotion to healthcare professionals only for packs containing more than 24 unit dosage forms.
Marketing StatusNot marketed

Documents

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