SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

Asda Mentholated Bronchial Balsam

Bell’s Healthcare Mentholated Bronchial Balsam Oral Solution Broncold™ Syrup Mentholated

Essential Waitrose Mentholated Bronchial Balsam Oral Solution Fitzroy Mentholated Koff & Kold Syrup (Export Only)

Friar Tuck's Herbal Bronchial Balsam

Gordons Chesty Cough Linctus Oral Solution

Morrisons Mentholated Bronchial Balsam Oral Solution

Natures Aid Health Products Traditional Herbal Bronchial Balsam

Numark Mentholated Bronchial Balsam

Sainsbury’s Bronchial Balsam Oral Solution

Superdrug Bronchial Balsam Oral Solution

Tesco Mentholated Bronchial Balsam

The co-operative Mentholated Bronchial Balsam Oral Solution Vantage Mentholated Bronchial Balsam Oral Solution Wilko Mentholated Bronchial Balsam

QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains:

Levomenthol BP    1.0 mg

Aniseed Oil BP    0.0035 ml

Capsicum Tincture BPC    0.025 ml

PHARMACEUTICAL FORM

Oral Solution

CLINICAL PARTICULARS Therapeutic Indications

For the symptomatic relief of sore throats, coughs, colds and catarrh.

Posology and Method of Administration

Oral

Either

a)	Adults	10 ml every hour
	Children 6 to 12 years	5 ml every hour
	Children 3 to 6 years	5 ml every 2 hours
Or
b)	Adults	10 ml or 15 ml every 2 or 3 hours
	Children 6 to 12 years	5 ml or 10 ml every 2 or 3 hours
	Elderly	As adults

4.3. Contra-indications

None stated

4.4. Special Warnings and Special Precautions for Use

None stated

4.5. Interactions with other Medicinal Products and other Forms of Interaction

None stated

4.6. Pregnancy and Lactation

None stated

4.7. Effects on Ability to Drive and Use Machines

None stated

4.8 Undesirable effects None stated

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None stated

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Menthol relieves the symptoms of bronchitis, sinusitis and similar conditions. In small doses it has a carminitive action.

Capsicum tincture is carminitive.

Aniseed oil is aromatic, carminitive and has expectorant properties.

5.2. Pharmacokinetic Properties

None stated

5.3    Preclinical safety data

There is no preclinical data available specific to the product.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ginger Oleoresin Clove Oil Peppermint Oil Glycerin Liquid Glucose Sucrose

Tragacanth Powder Benzoic Acid Caramel

Benzoin Tincture Tolu Tincture Ethanol 90%

Purified Water

6.2. Incompatibilities

None stated

36 months in the unopened container.

6.4. Special Precautions for Storage

Do not store above 25°C.

6.5 Nature and contents of container

White flint glass bottle or amber glass bottle with polypropylene, tinplate or ureaformaldehyde cap. Aluminium/melinex wad.

75 ml, 100 ml, 125 ml, 150 ml, 175 ml, 200 ml, 225 ml 250 ml, 300 ml and 500 ml.

6.6. Instruction for Use, Handling and Disposal

None

7 MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Limited

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

8. MARKETING AUTHORISATION NUMBER

PL 03105/0052

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1^st April 1997 / 26^th August 1998

10 DATE OF REVISION OF THE TEXT

10/04/2015