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WOODWARDS BABY COUGH LINCTUS

Active substance(s): DILUTE ACETIC ACID

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Transcript
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 2½ years: two 5ml spoonfuls.
Repeat as needed every 2 or 3 hours.
Not appropriate for adults or the elderly.

4.3
Contraindications
None stated.

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.

5.3
Preclinical safety data
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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