Vicks Cough Syrup for Chesty Coughs

1. Name Of The Medicinal Product

Vicks Cough Syrup for Chesty Coughs

2. Qualitative And Quantitative Composition

ACTIVE INGREDIENTS

	%w/v	Specification
Guaifenesin	1.333	Ph. Eur.

3. Pharmaceutical Form

Syrup for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

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

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.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

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.

4.7 Effects On Ability To Drive And Use Machines

None expected.

4.8 Undesirable Effects

Gastrointestinal discomfort has been reported.

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.

5. Pharmacological Properties

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.

5.2 Pharmacokinetic Properties

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

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose.

Sodium saccharin.

Propylene glycol.

Ethanol 96%.

Sodium citrate, hydrous.

Citric acid, anhydrous.

Carboxymethylcellulose sodium.

Polyethylene oxide.

Flavour 9512 (David Michael Heat)

Black cherry flavour RF 1195.

Levomenthol.

Menthoxypropanediol (TK10).

Macrogol stearate 40.

Sodium benzoate.

CI 16255 Acid red 18 (E124 Ponceau 4R).

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf life (unopened): 3 years

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Amber cylindrical glass bottle (pharmaceutical type III) with a Crab claw seal (polypropylene) child resistant closure:

Bottles containing 15ml, 30ml, 100ml, 120ml, 180ml of product are available

6.6 Special Precautions For Disposal And Other Handling

No specific instructions required.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Ltd.,

The Heights,

Brooklands,

Weybridge,

Surrey,

KT13 0XP.

8. Marketing Authorisation Number(S)

PL 0129/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

19 June 1996

10. Date Of Revision Of The Text

Oct 2009