VICKS ORIGINAL COUGH SYRUP CHESTY Per Cent Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GUAIFENESIN CETYLPYRIDINIUM CHLORIDE SODIUM CITRATE

Available from:

Procter & Gamble (Health & Beauty Care) Limited

INN (International Name):

GUAIFENESIN CETYLPYRIDINIUM CHLORIDE SODIUM CITRATE

Dosage:

Per Cent

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2013-03-21

Summary of Product characteristics

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0441/007/002
Case No: 2069833
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROCTER & GAMBLE (HEALTH & BEAUTY CARE) LTD
THE HEIGHTS, BROOKLANDS, WEYBRIDGE, SURREY KT13 0XP, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VICKS ORIGINAL COUGH SYRUP CHESTY
GUAIFENESIN 50MG/5ML
CETYLPYRIDINIUM CHLORIDE 1.25MG/5ML
SODIUM CITRATE 200MG/5ML
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 13/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/05/2010_
_CRN 2069833_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vicks Original Cough Syrup Chesty
Guaifenesin 50mg/5ml
Cetylpyridinium Chloride 1.25mg/5ml
Sodium Citrate 200mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the syrup contains Gaifenesin 50 mg, Cetylpridinium Chloride 1.25 mg and Sodium Citrate 200 mg.
Excipients: Each 5ml of syrup contains glucose 1.8g, sucrose 1.8g, ethanol 0.4g.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
A clear reddish-pink syrup having a characteristic cherry/aromatic aroma and taste.
4 CLI