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GALLOWAYS COUGH EXPECTORANT

Active substance: GUAIFENESIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Galloway’s Cough Expectorant

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Guaifenesin

1.50% w/v

For excipients see 6.1.

3.

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of chesty coughs, hoarseness and sore throats associated with
upper respiratory tract infections.

4.2

Posology and method of administration

Route of administration: oral.
Adults and the elderly: 10 ml maximum every 2-3 hours.
Children 3-12 years: 5 ml maximum every 2-3 hours.

4.3.

Contraindications
Galloway’s Cough Expectorant is contraindicated in individuals with known
hypersensitivity to the product or any of its components.

4.4

Special warnings and precautions for use

Not more than twelve doses should be given in any 24 hours. Do not exceed the
stated dose.
Do not take with any other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children under 6
years.
4.5.

Interactions with other medicinal products and other forms of interaction
None known.

4.6.

Pregnancy and lactation
No known restrictions.

4.7.

Effects on ability to drive and use machines
None known.

4.8.

Undesirable effects
None known.

4.9.

Overdose
Excessive overdose will cause self-limiting vomiting.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Guaifenesin is reported to have effects on lowering the viscosity of tenacious
sputum.

5.2.

Pharmacokinetic properties
Not applicable.

5.3.

Preclinical safety data
No pre-clinical safety problems have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Invert Sugar
Sodium Benzoate (E211)
Sodium Citrate
Acetic Acid (80% pure)
Citric Acid Monohydrate
Ethanol 96%
Menthol
Aniseed Flavour FP682/A
Cough Flavour 580.107/T
Caramel 15712 (E150)
Filtered tap water

6.2.

Incompatibilities
None known.

6.3.

Shelf life
24 months.

6.4.

Special precautions for storage
None

6.5

Nature and contents of container
75 ml bottle: R.O.P.P. Aluminium cap or plastic cap.
150 ml bottle: R.O.P.P. Aluminium cap or plastic cap.
300 ml bottle: R.O.P.P. Aluminium cap or plastic cap.

6.6.

Instructions for use, handling, (and disposal)
None

7

MARKETING AUTHORISATION HOLDER

Chefaro UK Ltd
4th Floor, Hamilton House
Mabledon Place
Bloomsbury
LONDON
WC1H 9BB
United Kingdom
8.
MARKETING AUTHORISATION NUMBER
PL 02855/0027

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/11/2004

10

DATE OF REVISION OF THE TEXT
21/06/2010

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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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