1. Name of the medicinal product
BENYLIN Chesty Coughs (Non-drowsy)

Benylin Mucus Cough

2. Qualitative and quantitative composition
Each 5ml of product contains 100 mg guaifenesin and 1.1 mg levomenthol.

Also contains:

Ethanol

Glucose

Sucrose

Sodium

Ponceau 4R (E124)
 0.2595ml/5ml

3492 mg/5ml

999 mg/5ml

16.42 mg/5ml
 

For full list of excipients, see Section 6.1.

3. Pharmaceutical form
Clear red syrup

4. Clinical particulars
4.1 Therapeutic indications
BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic relief of cough.

4.2 Posology and method of administration
Adults and children aged 12 years and over:

Oral. Two 5 ml spoonfuls four times a day.

Children under 12 years:

This product is contraindicated in children under the age of 12 years (see section 4.3).

The Elderly:

As for adults.

Hepatic/renal dysfunction

Experience with the use of this product suggests that normal adult dosage is appropriate for mild to moderate dysfunction. Caution should be exercised in severe hepatic and severe renal impairment. [See Pharmacokinetics].

Do not exceed the stated dose.

Keep out of the reach and sight of children.

4.3 Contraindications
This product is contraindicated in individuals with known hypersensitivity to the product, or any of its components.

Not to be used in children under the age of 12 years.

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.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment, [See Pharmacokinetics].

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5ml dose, equivalent to approximately 5 ml beer, 2 ml wine per 5 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 disease or epilepsy.

This product contains 16.42mg of sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.

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

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).

4.6 Fertility, pregnancy and lactation
Pregnancy

There are no or limited amount of data from the use of Guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Insufficient information is available on the effects of administration of this product during human pregnancy. This product is not recommended during pregnancy and in women of childbearing potential not using contraception

Breastfeeding

Guaifenesin is excre