Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
PARACETAMOL PHOLCODINE PSEUDOEPHEDRINE HYDROCHLORIDE
The Boots Company Plc
600/10/40 mg/30ml
Oral Solution
1983-04-13
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0004/026/001 Case No: 2032173 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to THE BOOTS COMPANY PLC 1 THANE ROAD, NOTTINGHAM NG2 3AA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DAY COLD COMFORT The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 07/02/2007 until 12/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/02/2007_ _CRN 2032173_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Day Cold Comfort 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral solution A clear, orange slightly viscous solution with a menthol and mixed fruit flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the symptoms of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children over 12 years: 30ml Children 6 to 12 years: 15ml Doses may be repeated every 4 hours, up to a maximum of 4 doses in 24 hours if needed. Children under 6 years: Not to be given to children under 6 years of age. 4.3 CONTRAINDICATIONS 1. Use in patie Przeczytaj cały dokument