1 NAME OF THE MEDICINAL PRODUCT

Asda Chesty Cough Syrup Guaifenesin Cherry Flavour

Bell’s Healthcare Mucus Cough Guaifenesin 100mg/5ml Oral Solution

Essential Waitrose Chesty Cough Guaifenesin 100 mg/5ml Oral Solution

Numark Mucus Cough Guaifenesin 100 mg/5 ml Oral Solution

Sainsbury’s Adult Chesty Cough Syrup Guaifenesin 100mg/5ml Oral Solution

Sainsbury’s Healthcare Mucus Cough Syrup Guaifenesin 100 mg/5 ml Oral Solution

Superdrug Chesty Cough Guaifenesin 100 mg/5 ml Oral Solution

Superdrug Mucus Cough Guaifenesin 100mg/5ml Oral Solution

Tesco Adult Chesty Cough Syrup

The Co-operative Chesty Cough Liquid Guaifenesin 100mg/5ml Oral Solution Wilko Mucus Cough 100mg/5ml Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains Guaifenesin BP 100 mg

3    PHARMACEUTICAL FORM

Oral solution

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Expectorant for symptomatic relief of coughs due to upper respiratory tract infections.

4.2    Posology and method of administration

Adults, the elderly and children over 12 years of age take 5 to 10 ml every two or three hours.

Not more than 4 doses should be given in any 24 hours.

Do not exceed the stated dose.

Do not take with any other cough and cold remedies.

Not recommended for children under 12 years Keep out of the sight and reach of children.

4.3    Contraindications

None

4.4 Special warnings and precautions for use

Not recommended for children under 12 years

4.5 Interaction with other medicinal products and other forms of interaction

A metabolite of guaifenesin was found to produce an apparent increase in urinary 5-hydroxyindoleacetic acid and could thus interfere with diagnosis of carcinoid syndrome. Patients should discontinue using this preparation 24 hours before the collection of urine samples for 5-hydroxyindoleacetic acid determination.

4.6 Pregnancy and lactation

No adverse effects reported.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

May cause gastro-intestinal discomfort. Large doses may cause nausea and vomiting.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.yellowcard.mhra.gov.uk.

4.9 Overdose

Not known.

5    PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Guiafenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It has been given in doses of 100 mg to 200 mg every 2 to 4 hours.

5.2 Pharmacokinetic properties

Guaifenesin is readily absorbed from the gastro-intestinal tract. It is readily metabolised and excreted in the urine.

5.3 Preclinical safety data

None available.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glucose Liquid

Methyl Hydroxybenzoate BP Citric Acid Anhydrous BP Sodium Citrate BP Sodium Saccharin BP

Carmoisine Caramel E150 Morello Cherry Flavour Alcohol 90% BP Purified Water BP

6.2 Incompatibilities

None known

6.3 Shelf life

36 months in unopened bottle.

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Bottle: Amber (Type III) glass

Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner

OR

Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner

Sizes: 50 ml, 60 ml, 100 ml, 125 ml, 150 ml, 175 ml, 200 ml, 225 ml, 250 ml and 300 ml.

30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml, 4 ml, 5 ml, 7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.

(May not be included in all marketed products)