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

Licence status
Authorised: 10/09/2021
Active substances
Paracetamol, Guaifenesin, Phenylephrine hydrochloride
Dosage Form
Capsule, hard
Licence number
PA1186/025/001
Licence holder
Chefaro Ireland DAC,

Licence information

ATC code
N02BE51 paracetamol, combinations excl. psycholeptics
Legal supply status
Product not subject to medical prescription
Place of sale
Supply through pharmacies only
Conditions of Licence
Pharmacy 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 availability
Not marketed
Advertising conditions
Advertising to the general public
Licence issued
10/09/2021