Pfizer Consumer Healthcare

Robitussin Dry Cough 7.5 mg / 5ml Oral Solution

Each 5 ml of liquid contains;

Active ingredient:

Dextromethorphan Hydrobromide 7.5 mg

Excipients:

For a full list of ingredients, see 6.1

Oral Solution

A clear, red liquid with the characteristic odour and taste of cherry / grenadine

As a cough suppressant for the relief of non-productive irritant cough

Taken orally

Use in children under 12 years of age.

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

Robitussin Dry Cough should only be used under medical supervision for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or where the cough is accompanied by excessive secretions.

If the product is abused by patients they may become dependant on it.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Patients who are taking other medication and/or are under the care of a physician, should consult their doctor before taking the product.

Do not exceed the recommended dose.

If symptoms persist for more than 7 days or you have a recurrent cough, consult your doctor or pharmacist.

This product contains 2.1 % w/v per 5 ml of ethanol (96%) which should be taken into consideration for those suffering from alcoholism, those who are pregnant or breastfeeding or high risk groups such as patients suffering from liver disease or epilepsy.

This product contains amaranth (E123) which may cause allergic reactions.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Keep out of the reach and sight of children.

Anti-depressants

Fluoxetine / Paroxetine: Hallucinations and serotonin syndrome may occur.

Use with caution in patients receiving monoamine oxidase inhibitors, or within two weeks of stopping treatment.

Anti-arrhtyhmics

Quinodine and Amiodarone can increase the concentration of Dextromethorphan.

Anti-bacterials:

Linezolid: Serotonin like symptoms have occurred when Dextromethorphan has been taken with Linezolid.

Although Dextromethorphan has been in widespread use for many years without apparent ill effect, the safe use of this product in pregnancy has not been established.

It is not known whether dextromethorphan or its metabolites are excreted in human milk. Caution should therefore be exercised by balancing the potential benefit of treatment against any possible hazards. This product should only be taken by breast-feeding mothers when considered essential by the physician.

None known

Adverse effects with dextromethorphan hydrobromide are rare and may include dizziness, gastrointestinal upset and the possibility of hypersensitivity reactions.

Excitation, confusion, and respiratory depression may occur after overdosage. Gastric lavage and supportive measures should be used.

Dextromethorphan hydrobromide is a cough suppressant, which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.

Dextromethorphan hydrobromide is well absorbed from the GI tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites of dextromethorphan, which have some cough suppressant activity.

Not applicable

Glycerol

Croscarmellose Sodium

Sodium Benzoate (E211)

Disodium Edetate

Maltitol Liquid

Citric Acid Anhydrous

Amaranth (E123)

Caramel (E150)

Levomenthol

Cherry / Grenadine Flavour

Sorbitol Solution (70%) (E420)

Sodium Cyclamate

Acesulfame Potassium Salt

Purified Water

Ethanol (96% v/v)

Not Applicable

PET Bottles: 3 years

Do not store above 25°C

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

A clear polypropylene measuring cup is also included.

No special requirements

Pfizer Consumer Healthcare Ltd,

Ramsgate Road, Sandwich,

Kent, CT13 9NJ,

United Kingdom.

PA 172/33/2

Date of first authorisation: 18^th December 1985

Date of last renewal: 18^th December 2010

September 2011