Pfizer Consumer Healthcare

Robitussin Chesty Cough 100mg/5ml Oral Solution

Each 5 ml contains 100 mg guaifenesin

This product also contains ethanol (107mg per 5ml), maltitol (E965) and sorbitol (E420).

For a full list of excipients, see section 6.1

Oral solution

A deep wine-russet coloured oral solution with a raspberry odour and taste.

Expectorant used as an adjunct in the treatment of productive cough.

Use in children under 12 years of age.

Hypersensitivity to the active substance or to any of the excipients.

Caution should be exercised in patients with chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.

A doctor or healthcare professional should be sought if cough lasts more than 5 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

This product should not be taken with any other cough and cold medicine.

This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

None stated

None Stated

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

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

The following signs and symptoms may be associated with an overdose of Guaifenesin:

Gastrointestinal disorders

Nausea, vomiting

Treatment is by gastric lavage together with appropriate supportive therapy dependent upon individual response to the various constituents of the preparation.

Guaifenesin is a proven expectorant which loosens mucus in the chest and make it easier to bring out.

Guaifenesin is absorbed from the GI tract. It undergoes metabolism and is excreted in the urine.

None Stated

Glycerol

Carmellose sodium

Sodium Benzoate

Ethanol

Levomenthol

Citric Acid Anhydrous

Liquid Maltitol (Lycasin 80/55) (E965)

Caramel E150

Natural Cherry Flavour*

Liquid Sorbitol Non-Crystallising (E420)

Sodium Cyclamate

Acesulfame Potassium Salt

Purified Water

* contains: ethanol, propylene glycol and natural flavourings

Not applicable

27 months

Do not store above 25°C

PET bottles containing 100ml with PET-lined PP/HDPE child resistant screw caps.

A clear polypropylene measuring cap is also included.

No special requirements

Pfizer Healthcare Ireland,

9 Riverwalk, National Digital Park,

Citywest Business Campus, Dublin 24.

PA 822/170/1

Date of first authorisation: 1^st April 1983

Date of last renewal: 1^st April 2008

March 2015