Mentholated Bronchial Balsam
1 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 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 Wilko Mentholated Bronchial Balsam
2 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
3. PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1
Therapeutic Indications
4.2. Posology and Method of Administration
Oral
Either
a) Adults
Children 6 to 12 years Children 3 to 6 years
Or
b) Adults
Children 6 to 12 years
Elderly
10 ml every hour 5 ml every hour 5 ml every 2 hours
10 ml or 15 ml every 2 or 3 hours 5 ml or 10 ml every 2 or 3 hours
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.
4.9. Overdose
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.
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
None stated
6.3. Shelf Life
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
1st April 1997 / 26th August 1998
10 DATE OF REVISION OF THE TEXT
24/05/2016