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Procter & Gamble (Health & Beauty Care) Ltd.

The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK

Telephone: +44 (0)191 297 5000
Fax: +44 (0)191 297 6295
WWW: http://www.uk.pg.com
Customer Care direct line: +44 (0) 8000 850367 (UK)

Customer Care direct line: +353 (1) 800 509 301 (Ireland)

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Summary of Product Characteristics last updated on the eMC: 19/03/2012

SPC	Vicks Vaporub

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Vicks Vaporub

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Name of the active substances:	Quantity	Unit	Reference standards
LEVOMENTHOL	2.75	% W/W	Eur. Ph
CAMPHOR	5.00	% W/W	Eur. Ph
EUCALYPTUS OIL	1.50	% W/W	Eur. Ph
TURPENTINE OIL	5.00	% W/W	FP

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3. PHARMACEUTICAL FORM

An ointment which is rubbed on chest or added to hot water and the aromatics are inhaled.

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4.1 Therapeutic indications

For the symptomatic relief of nasal catarrh and congestion, sore throat, also cough due to colds.

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4.2 Posology and method of administration

Adults:

Rub Vaporub liberally on the chest, throat and back. Rub in well over the whole area and leave nightclothes loose for easy inhalation.

Melt two teaspoons of Vaporub in very hot water and inhale the vapours.

Children (infants and babies over 2 years):

Apply lightly to chest and back. Rub gently and leave clothes loose for easy inhalation.

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4.3 Contraindications

Vicks Vaporub is contraindicated in children under 2 years.

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4.4 Special warnings and precautions for use

In case of fever consult your doctor.

Do not swallow or place in nostrils.

As with all medicines keep out of the reach of children.

If symptoms persist consult your doctor.

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4.5 Interaction with other medicinal products and other forms of interaction

None.

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4.6 Pregnancy and lactation

Although there is no evidence of any risk when Vaporub is used in pregnancy, such use is not recommended without medical advice.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

None.

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4.9 Overdose

Overdosage may result in skin irritation.

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5.1 Pharmacodynamic properties

Menthol, camphor, turpentine oil and eucalyptus oil act locally in the respiratory tract.

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5.2 Pharmacokinetic properties

The product exerts its action locally; little or no absorption is expected to occur.

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5.3 Preclinical safety data

Not applicable.

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6.1 List of excipients

Thymol

Cedarwood oil

White soft paraffin

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6.2 Incompatibilities

None.

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6.3 Shelf life

48 months.

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6.4 Special precautions for storage

Do not store above 25^oC.

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6.5 Nature and contents of container

VapoRub ointment is packed into 40g, 50g, 90g and 100g opaque, blue, polypropylene jars, closed with a green polypropylene thread screw cap and containing a 2mm thick PET/LDPE/EPE/LDPE/PET cap liner.

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6.6 Special precautions for disposal and other handling

None.

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7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

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