Beechams Veno’s Honey and Lemon

1. Name Of The Medicinal Product

Beecham's Veno's Honey & Lemon

Veno's Honey & Lemon Syrup

2. Qualitative And Quantitative Composition

Glucose, liquid 4.00 g, Purified Honey 0.29 g, Lemon Juice Concentrate 0.25 g (equivalent to Lemon Juice 0.9 ml).

For excipients, see 6.1.

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of tickly coughs and sore throats.

4.2 Posology And Method Of Administration

Route of Administration

Oral

Dosage Instructions

Adults (including the elderly) and children aged 12 years and over:

Take a 15 ml dose (three 5 ml spoonfuls) and repeat every two to three hours.

Do not exceed 8 doses in any 24 hours.

Children aged 6 to under 12 years:

Take a 10 ml dose (two 5 ml spoonfuls) and repeat every two to three hours.

Children aged 2 to under 6 years:

Take a 5 ml dose (one 5 ml spoonful) and repeat every two to three hours.

Do not exceed 4 doses in any 24 hours. Do not exceed the stated dose.

Consult a pharmacist or other healthcare professional before use in children under 6 years.

Do not take with any other cough and cold medicine.

Not to be given to children under two years of age.

4.3 Contraindications

Known hypersensitivity to any of the constituents.

4.4 Special Warnings And Precautions For Use

Labelling

Keep all medicines out of the sight and reach of children.

If symptoms persist, consult your doctor.

Carbohydrate content: 3.5 g per 5 ml.

Children aged 2 to under 6 years:

Consult a pharmacist or other healthcare professional before use in children under 6 years.

Do not take with any other cough and cold medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

The product is not contraindicated during pregnancy and lactation. However, the advice of a doctor should be sought before use.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

There are no side effects associated with normal use of the product.

4.9 Overdose

The product does not contain any ingredient in a high enough concentration to cause toxic effects; therefore no special symptoms of overdosage would be anticipated and no antidotes would be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glucose liquid, honey and lemon juice are demulcents.

5.2 Pharmacokinetic Properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oropharyngeal cavity and the constituents are systematically innocuous in the concentration used.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ammonium chloride, citric acid monohydrate, xanthan gum, sodium metabisulphite, sodium benzoate, sodium citrate, levomenthol, propylene glycol, water, lemon flavour 730024E, honey flavour 510553E and caramel colour.

6.2 Incompatibilities

None known

6.3 Shelf Life

Unopened: Three years

Opened: Six months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Cylindrical glass bottle with a roll-on, pilfer proof, aluminium cap, containing a melinex-coated, aluminium-faced pulp-board wad. Each bottle is packed in a boxboard carton together with a graduated, polypropylene measuring cup. Pack sizes: 100 or 160 ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/5037R

9. Date Of First Authorisation/Renewal Of The Authorisation

06/10/2005

10. Date Of Revision Of The Text

02/12/2010