Search for:

Search Medicine or Company Name Search Full Document

Advanced Search

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)

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 04/08/2010

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

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Vicks Cough Syrup for Chesty Coughs

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS

	%w/v	Specification
Guaifenesin	1.333	Ph. Eur.

Go to top of the page

3. PHARMACEUTICAL FORM

Syrup for oral administration.

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

To relieve a cough, loosen mucus, soothe and coat the throat and make the cough more productive.

Go to top of the page

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

Go to top of the page

4.3 Contraindications

Not to be used in children under the age of 6 years

Known hypersensitivity to guaifenesin.

Go to top of the page

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not administer to children under 2 years except on medical advice.

If symptoms persist, consult your doctor.

Keep out of reach of children.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Go to top of the page

4.6 Pregnancy and lactation

There is no literature evidence of hazard due to guaifenesin but, as with all medicines, use is not recommended during the first trimester and during breast feeding.

Go to top of the page

4.7 Effects on ability to drive and use machines

None expected.

Go to top of the page

4.8 Undesirable effects

Gastrointestinal discomfort has been reported.

Go to top of the page

4.9 Overdose

4.9.1 Symptoms

Symptoms of very large overdose include nausea and vomiting. Any absorbed guaifenesin is, however, rapidly metabolised and excreted in the urine.

4.9.2 Management of an overdose

Treatment is supportive and symptomatic.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

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.

Go to top of the page

5.2 Pharmacokinetic properties

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

Go to top of the page

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.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Sucrose.

Sodium saccharin.