Boots Mild Vapour Rub

Boots Children's Vapour Rub

Ointment

For head colds, stuffy nose, cough and chest colds.

For children over 2 years and adults

Apply a small amount on the chest and back particularly at bedtime. Rub gently and leave clothes loose for easy inhalation. Apply a moderate amount on older children and adults.

Elderly

There is no need for dosage reduction.

Children under 2 years

Not recommended for children under 2 years of age.

For topical application.

Hypersensitivity to any of the ingredients.

Do not use on children under 2 years of age.

For external use only.

Do not apply around the nostrils, mouth, eyes or face.

Do not use on broken skin or wounds.

Keep all medicines out of the sight and reach of children.

Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.

No clinically significant drug interactions known.

The safety of vapour rub during fertility, pregnancy and lactation has not been established. As a precaution this product should not be used without medical advice during pregnancy. This product should not be used on the mother's chest during breastfeeding.

No adverse effects known.

Occasional hypersensitivity and irritant skin reactions.

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Overdosage may result in skin irritation.

Misuse:

Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.

Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.

Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain and headache, vertigo, feeling hot/flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

Convulsions may be controlled by the intravenous administration of diazepam 5-10 mg.

Eucalyptus oil, camphor, levomenthol are volatile substances and are thought to produce an irritant effect on the respiratory tract, probably via a nasal/pulmonary arc.

None stated.

Not applicable.

White soft paraffin

None stated.

36 months in amber glass jar.

20 months in polystyrene jar.

Amber glass jar - None.

Polystyrene jar - Do not store above 25°C.

Amber glass jar with either a tin plate cap with waxed aluminium faced pulpboard liner containing 45g or a thermoset plastic cap

or

A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.

None.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0562

31 May 1996

27^th January 2020