Vicks Original Cough Syrup Chesty - Summary of Product Characteristics (SPC)

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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)

Summary of Product Characteristics last updated on medicines.ie: 13/08/2010

SPC	Vicks Original Cough Syrup Chesty

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 excipient(s)
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 Original Cough Syrup Chesty

Guaifenesin 50mg/5ml

Cetylpyridinium Chloride 1.25mg/5ml

Sodium Citrate 200mg/5ml

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of the syrup contains Gaifenesin 50 mg, Cetylpridinium Chloride 1.25 mg and Sodium Citrate 200 mg.

Excipients: Each 5ml of syrup contains glucose 1.8g, sucrose 1.8g, ethanol 0.4g.

For full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Syrup.

A clear reddish-pink syrup having a characteristic cherry/aromatic aroma and taste.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Treatment of nasopharyngeal irritation and relief of productive cough.

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4.2 Posology and method of administration

Adults and children over 12years: 10 ml (2 teaspoons) to be repeated every three hours as needed

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4.3 Contraindications

None.

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4.4 Special warnings and precautions for use

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

No specific data available

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4.7 Effects on ability to drive and use machines

None

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4.8 Undesirable effects

Guaifenesin has been reported occasionally to cause gastrointestinal discomfort.

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4.9 Overdose

Treatment of overdose

Symptomatic management

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Guaifenesin and sodium citrate are expectorants which are believed to work by increasing bronchial secretion and reducing the viscosity of sputum. Cetylpyridinium chloride is a surfactant and antibacterial agent, having a local antiseptic effect.

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5.2 Pharmacokinetic properties

Guaifenesin is rapidly metabolised and excreted in the urine mainly as -(2-Methoxy Phenoxy) Lactic acid.

Sodium citrate is oxidised to bicarbonate and excreted in the urine.

Cetylpyridinium chloride acts locally and, being cationic in nature would not be expected to be absorbed systematically. It would therefore be excrete unchanged in the faeces.

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5.3 Preclinical safety data

Not applicable.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sodium benzoate (E211)

Citric acid monohydate

Glycerol

Liquid Glucose

Sucrose

Ethanol 96 %

Tingle flavour EAD 2576

Propylene glycol

Cochineal

Levomenthol

Camphor

Eucalyptus oil

Vicks flavour (FD&O 23143)

Purified water

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

2 years

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6.4 Special precautions for storage

Do not store above 25°C.

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6.5 Nature and contents of container

100 ml coated amber glass bottle with wadless polypropylene screw cap or polypropylene child resistant closure.

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6.6 Special precautions for disposal and other handling

Shake well before use.

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7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Ltd.

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

United Kingdom

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8. MARKETING AUTHORISATION NUMBER(S)

PA 441/7/2

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29 September 1982Date of last renewal: 29 September 2007

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10. DATE OF REVISION OF THE TEXT

May 2010

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Active Ingredients

Sodium Citrate

Guaifenesin

Cetylpyridinium Chloride

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