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

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 09/05/2012 and displayed until Current

Reasons for adding or updating:
Change to section 4.1 - Therapeutic indications Change to section 4.4 - Special warnings and precautions for Use Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Date of revision of text on the SPC: 20-Mar-2012
Legal Category: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
4.1 THERAPEUTIC INDICATIONS To relieve a cough deleted Expectorant for the symptomatic relief of acute productive (chesty) cough, which added to added and deleted 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema added Do not take with a cough suppressant added for more than 5 days, or the cough comes back, stop use and added a healthcare professional added your doctor deleted 4.5 INTERACTION WITH OTHER MEDICAMENTS 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) added none known deleted 4.8 UNDESIRABLE EFFECTS Gastrointestinal Disorders: Nausea, vomiting and diarrhoea, may occur rarely with guaifenesin added Gastrointestinal discomfort has been reported deleted Immune System Disorders: Hypersensitivity reactions added 10. DATE OF (PARTIAL) REVISION OF TEXT December 2010 deleted 20/03/2012 added

Updated on 04/08/2010 and displayed until 09/05/2012

Reasons for adding or updating:
Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Oct-2009
Legal Category: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 6.5: Amber cylindrical glass bottle (pharmaceutical type III) with a high density polyethylene screw thread closure has been changed to Amber cylindrical glass bottle (pharmaceutical type III) with a Crab claw seal (polypropylene) child resistant closure Section 10: June 2009 has been changed to October 2009

Updated on 17/08/2009 and displayed until 04/08/2010

Reasons for adding or updating:
Change to section 4.2 - Posology and method of administration Change to section 4.3 - Contraindications
Date of revision of text on the SPC: 08-Jun-2009
Legal Category: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
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 4.3 Contraindications Not to be used in children under the age of 6 years Known hypersensitivity to guaifenesin.

Updated on 14/01/2009 and displayed until 17/08/2009

Reasons for adding or updating:
Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC: 03-Apr-2006
Legal Category: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Before 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and over: 3 x 5ml spoonfuls Children (6-11 years): 2 x 5ml spoonfuls Children (2-5 years): 1 x 5ml spoonful Repeat every 4 hours as needed. No more than 6 doses a day After 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and over: 3 x 5ml spoonfuls Children (6-11 years): 2 x 5ml spoonfuls Children (2-5 years): 1 x 5ml spoonful Children under 6: Do not take with any other cough and cold medicine. Consult a pharmacist or other healthcare professional for further advice. Repeat every 4 hours as needed. No more than 6 doses a day