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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: 09/05/2012

SPC	Vicks Cough Syrup for Chesty Coughs

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
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. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
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 Cough Syrup for Chesty Coughs

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS

	%w/v	Specification
Guaifenesin	1.333	Ph. Eur.

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3. PHARMACEUTICAL FORM

Syrup for oral administration.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Expectorant for the symptomatic relief of acute productive (chesty) cough, which loosens mucus, soothes and coats the throat to make the cough more productive.

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4.2 Posology and method of administration

Adults and children 12 years and over:

3 x 5ml spoonfuls

Repeat every 4 hours as needed.

No more than 6 doses a day

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4.3 Contraindications

Not to be used in children under the age of 12 years

Known hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Do not exceed the stated dose.

Do not take with a cough suppressant.

If symptoms persist for more than 5 days, or the cough comes back, stop use and consult a healthcare professional.

Keep out of reach and sight of children.

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4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of Vicks Cough Syrup for Chesty Coughs a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

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4.6 Pregnancy and lactation

The safety of Guaifenesin in pregnancy and lactation has not been fully established. The product should only be used in pregnancy or lactation on the advice of a doctor.

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4.7 Effects on ability to drive and use machines

None expected.

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4.8 Undesirable effects

Gastrointestinal Disorders: Nausea, vomiting and diarrhoea, may occur rarely with guaifenesin.

Immune System Disorders: Hypersensitivity reactions

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4.9 Overdose

4.9.1 Symptoms

Mild to moderate overdose may cause dizziness or vertigo and gastrointestinal disturbances. Very high doses may produce symptoms such as excitation, confusion and respiratory depression.

4.9.2 Management of an overdose

Treatment is symptomatic, involving gastric lavage and general supportive measures.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Guaifenesin has an expectorant action which increases the output of the respiratory tract fluid by reducing surface tension. The increased flow of less viscid secretions promotes cilary action and facilitates the removal of mucous.

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5.2 Pharmacokinetic properties

Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

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5.3 Preclinical safety data

There are no pre-clinical data of relevance which are additional to that already included in the other sections of the SmPC.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sucrose.

Sodium saccharin.