BEECHAMS MAX STRENGTH COLD AND FLU

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

PARACETAMOL

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Dosage:

1000 Milligram

Pharmaceutical form:

Oral Powder

Authorization date:

2006-06-02

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)
PA0678/104/001
Case No: 2054166
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LIMITED
STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BEECHAMS MAX STRENGTH COLD AND FLU 1000 MG POWDER FOR ORAL SOLUTION.
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 11/09/2008 until 01/06/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/10/2008_
_CRN 2054166_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beechams Max strength Cold and Flu 1000mg Powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 1000mg of Paracetamol.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution
Pale yellow soluble powder with an odour and taste of lemon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic relief of influenza, feverishness, chills and colds including headache, sore throat pain,
sinusitis, aches and pains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administrat
                                
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