An expectorant for the relief of chesty coughs.

Adults and children over 12 years:

Two 5ml spoonfuls every four hours up to four times a day.

Children under 12 years:

Not recommended.

Elderly:

There is no need for dosage reduction in the elderly.

For oral administration

Hypersensitivity to the active substance or any of the excipients.

Not recommended for children under 12 years.

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Do not exceed the stated dose.

Do not take with a cough suppressant.

Keep all medicines out of the reach of children.

This medicine contains glycerin. May cause headache, stomach upset and diarrhoea.

This medicine contains liquid sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.

There are no clinically significant interactions.

If urine is collected within 24 hours of a dose of guaifenesin a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

If pregnant or breastfeeding, consult a healthcare professional before use.

Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester. An increased occurrence of inguinal hernias was found in the neonates. However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs.

Breastfeeding

Guaifenesin is excreted in breast milk in small quantities.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.

No adverse effects known.

The following side effects may be associated with the use of guaifenesin:

Gastrointestinal disorders: nausea, vomiting/gastrointestinal discomfort.

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

In case of overdose, discontinue use and seek professional assistance immediately.

Overdosage may give rise to nausea and vomiting.

Treatment need only be symptomatic and supportive.

Pharmacotherapeutic group: Expectorant ATC code: RO5CAO3

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.

Guaifenesin is readily absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

Not applicable.

Liquid sugar

Hydroxyethylcellulose

Glycerin

Flav F menthol E43525

Potassium sorbate

Acesulfame K

Citric acid monohydrate

Sodium citrate

Food flavour 511630E TM

Blackcurrant 17407107

Purified water

None stated

24 months

Do not store above 25° C.

Do not refrigerate or freeze

An amber PET bottle with a polypropylene child resistant cap fitted with an expanded polyethylene liner.

Pack size: 150ml, 240ml, 300ml

Not applicable.