Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

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 with Honey for Dry and Irritating 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 with honey for dry and irritating coughs

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS

	%w/v	Specification
LEVOMENTHOL	0.125	EP

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

For symptomatic relief of dry, irritating cough associated with the common cold.

Go to top of the page

4.2 Posology and method of administration

Adults and children over 12 years:	10ml every 3-4 hours maximum of 6 doses per day
Children 6-12 years:	5ml every 3-4 hours maximum of 6 doses per day
Children under 6 years:	Not recommended

Go to top of the page

4.3 Contraindications

Patients hypersensitive to menthol and propylene glycol

Go to top of the page

4.4 Special warnings and precautions for use

If symptoms persist for more than 7 days, consult your doctor.

Contains 9g of sugar (present as sucrose and glucose) per 10ml dose.

Diabetics should consult their doctor before using this product.

Not to be given to children under 6 years of age unless directed by a doctor.

If you are pregnant, consult your doctor before use.

Keep out of the reach of children.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None expected

Go to top of the page

4.6 Pregnancy and lactation

No specific information is available, however, the long history of use of menthol and propylene glycol, together with the food ingredient status of all constituents gives no evidence to suggest any adverse effects.

Go to top of the page

4.7 Effects on ability to drive and use machines

None

Go to top of the page

4.8 Undesirable effects

None known.

Go to top of the page

4.9 Overdose

4.9.1 Symptoms

Reports of Bradycardia and evidence of toxicity have occurred when a daily dose of over 180mg Of Menthol was administered for 7 Days. Ataxia, Confusion, Euphoria, Nystagmus and Diplopia have been reported in an overdose situation.

4.9.2 Treatment of overdose

Treatment is symptomatic

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Menthol provides an antitussive action and the syrup base contributes a demulcent effect.

Go to top of the page

5.2 Pharmacokinetic properties

It is hypothesised that menthol may have a topical effect. However, once swallowed, menthol is absorbed and metabolised to glucuronides which are mainly excreted in the urine.

Go to top of the page

5.3 Preclinical safety data

N/A

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Sucrose

Liquid Glucose

Honey

Propylene Glycol

Purified Water

Go to top of the page

6.2 Incompatibilities

None

Go to top of the page

6.3 Shelf life

24 Months

Go to top of the page

6.4 Special precautions for storage

Store below 25^oc. Do not refrigerate

Go to top of the page

6.5 Nature and contents of container

100ml, 120ml, 125ml, 150ml Or 200ml Brown Type III Coated Amber Glass Bottles with two piece crab claw seal (polypropylene) child resistant closure. Composed of two parts; an outer and inner part. The outer part does not come into contact with the product, whereas the inner part is in contact with the product. Not all pack sizes may be marketed.

Go to top of the page

6.6 Special precautions for disposal and other handling

None

Go to top of the page

7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Ltd.

The Heights

Brooklands

Weybridge

Surrey

Kt13 0xp

Go to top of the page