Benylin Tickly Coughs Non-Drowsy

For excipients see 6.1.

Oral liquid

For the relief of irritating, tickling dry coughs and sore throats.

For oral administration.

Adults and children over 5 years: 10 ml

Children 1 - 5 years: 5 ml

The dose may be repeated three or four times a day.

Children under one year: Not to be given to children under 1 year.

Elderly: There is no need for dosage reduction in the elderly.

Hypersensitivity or intolerance to any of the ingredients.

Diabetics should take note of the carbohydrate content of this product.

Do not give to children under one year.

Keep all medicines out of the reach of children.

Information relating specifically to excipients in the formulation.

This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

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

No clinically significant interactions known.

The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.

Not applicable.

No adverse effects would be anticipated.

Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.

Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.

Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Citric acid monohydrate

Sodium benzoate (E211)

Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol, ethanol (alcohol)

Black treacle

Liquid glucose

Purified water

Not applicable.

36 months.

No special precautions for storage.

A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.

Alternative cap: A wadless polypropylene tamper evident cap.

Pack size: 200ml.

or

An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal LDPE/EPE/LDPE) liner.

Pack size: 125ml and 150ml

or

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

Pack size: 150ml or 300ml.

Not applicable.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

PL 15513/0142

11th January 2005

6^th August 2010