Galloways Cough Expectorant
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
Nature and contents of container
6.5
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
Omega Pharma Ltd. 1st Floor 32 Vauxhall Bridge Road LONDON, SW1V 2SA 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
30/09/2014