1. Name of the medicinal product
Benylin Dual Action Night Cough & Congestion

Benylin Mucus Cough Night

2. Qualitative and quantitative composition
Each 5 ml contains Diphenhydramine hydrochloride 14 mg, Guaifenesin 100 mg and Levomenthol 1.1 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form
A clear red syrup with no insoluble matter.

4. Clinical particulars
4.1 Therapeutic indications
For the night time relief of cough, associated congestive symptoms and aiding restful sleep.

4.2 Posology and method of administration
For oral use.

Adults and children aged 12 years and over:

Patients may start with two 5 ml spoonfuls at bedtime followed by two 5 ml spoonfuls every 6 hours.

Or two 5 ml spoonfuls four times a day.

Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24 hours.

Children under 12 years:

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

Elderly (over 65 years):

As for adults.

Do not exceed the stated dose.

Keep out of the reach and sight of children.

4.3 Contraindications
Known hypersensitivity to the product or any of its constituents.

This product should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks.

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

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

Subjects with moderate to severe renal or hepatic dysfunction or urinary retention should exercise caution when using this product (see section 5.2).

This product contains diphenhydramine and should be used with caution in patients with narrow-angle glaucoma or symptomatic prostatic hypertrophy.

Avoid alcoholic drink.

The label contains the following statements:

May cause drowsiness. If affected, do not drive or operate machinery.

Avoid alcoholic drink. Do not use if bottle seal is broken when purchased. Keep bottle tightly closed. Do not store above 30°C. Keep out of the reach and sight of children. As with all medicines, if you are pregnant consult your doctor or pharmacist before taking this product.

4.5 Interaction with other medicinal products and other forms of interaction
This product contains diphenhydramine and therefore may potentiate the effects of alcohol, codeine, antihistamines and other CNS depressants.

As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (e.g. some psychotropic drugs and atropine) may be potentiated by this product. This may result in tachycardia, dry mouth, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

4.6. Pregnancy and lactation
As with any other medicine, care should be taken in administration during pregnancy. This product has not been associated with adverse effects in the human foetus or suckling infant.

4.7 Effects on ability to drive and use machines
This preparation may cause drowsiness. If affected, the patient should not drive or operate machinery.

4.8 Undesirable effects
Diphenhydramine may cause drowsiness, dizziness, gastrointestinal disturbanc