SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Baby Cough Syrup Woodwards Baby Cough Linctus Babelix Baby Cough Syrup Cupal Baby Cough Syrup Peels Baby Cough Syrup Tremletts Baby Cough Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Dilute acetic acid BP 0.420ml

3    PHARMACEUTICAL FORM

Oral liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of the irritating and distressing coughs which often accompany colds.

4.2 Posology and method of administration

Oral.

To be given slowly.

Children 3 months to 1 year: half a 5m1 spoonful. Over 1 year: one 5ml spoonful.

Over 2^2 years: two 5ml spoonfuls.

Repeat as needed every 2 or 3 hours.

Not appropriate for adults or the elderly.

4.4 Special warnings and precautions for use

Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

None stated.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Baby cough syrup contains dilute acetic acid (a mild expectorant) in a sugar free blackcurrant flavoured demulcent base

5.2 Pharmacokinetic properties

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tolu flavour solution (sugar free), methyl hydroxybenzoate, propyl hydroxybenzoate, carmellose sodium, sodium saccharin, sorbitol solution, blackcurrant flavour C3688, blackcurrant flavour 50013E, water.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

100ml: amber glass bottles with white polypropylene screw cap.

6.6 Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Limited, North Way,

Walworth Industrial Estate, Andover,

SP10 5AZ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0094

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/04/1990 / 24/11/2010

10 DATE OF REVISION OF THE TEXT

30/01/2008