1. Name of the medicinal product
Benylin Mucus Cough Menthol flavour 100 mg/5 ml Oral Solution

2. Qualitative and quantitative composition
This product contains 20 mg guaifenesin in each ml (100mg in 5ml).

Each ml also contains:

Ethanol 39.7mg

Ponceau 4R (E124) 0.05mg

Sodium 1.8mg

Glucose

Fructose

For a full list of excipients, see section 6.1.

3. Pharmaceutical form
Oral solution

Clear to slightly opalescent red liquid

4. Clinical particulars
4.1 Therapeutic indications
This product is indicated to help loosen phlegm and thin bronchial secretions associated with productive cough, for use in adults and adolescents over 12 years.

4.2 Posology and method of administration
Adults and adolescents over 12 years:

For oral administration: 10 ml (200mg guaifenesin) 4 times a day.

Maximum daily dose: 40ml (800mg guaifenesin)

Children under 12 years:

Not recommended.

The Elderly:

As for adults.

Hepatic/renal dysfunction

Caution should be exercised in severe hepatic and severe renal impairment.

If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

4.3 Contraindications
This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use
This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

A persistent cough may be a sign of a serious condition. If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment.

The concomitant use of cough suppressants is not recommended.

Patients with rare hereditary problems of fructose intolerance or glucose galactose malabsorption should not take this medicine.

This product contains 4.7 vol % ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to approximately 10 ml beer, 4 ml wine per 10 ml dose. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver or kidney disease or epilepsy.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This product contains 17.6mg sodium per 10ml dose. This should be taken into consideration by those on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid 5-HIAA) and vanillylmandelic acid (VMA).

Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.

No interaction studies have been performed which revealed an interaction with guaifenesin.

4.6 Fertility, pregnancy and lactation
Pregnancy

There are