Hills Balsam Chesty Cough Liquid
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HILL’S BALSAM CHESTY COUGH LIQUID FOR CHILDREN
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate BP 20 mg/5 ml and Ipecacuanha Liquid Extract BP 0.01 ml/5 ml
3 PHARMACEUTICAL FORM
Cloudy, straw-coloured, semi-viscous syrup with odour and sharp, sweet flavour of orange.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Where treatment with an expectorant and demulcent is indicated to relieve and soothe chesty coughs and bronchial catarrh in children under twelve years of age.
4.2 Posology and method of administration
For oral use only.
For Children aged 2 to 6 years:
Half a 5ml spoonful (2.5ml) three times a day and at bedtime.
Not more than 4 doses should be given in any 24 hours. (3 doses during the day and 1 dose at bedtime).
Do not exceed the stated dose.
Do not take with any other could and cold medicine.
Children aged 6 to 12 years:
One 5 ml spoonful three times a day and at bedtime.
Not recommended for children over 12 years, adults or the elderly.
4.3 Contraindications
None stated.
4.4 Special warnings and precautions for use
Medical advice should be sought if the condition worsens.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, Pregnancy and lactation
None stated.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
4.9 Overdose
In the event of ingestion of very large quantities of Hill’s Balsam Chesty Cough Liquid for Children and emetic response would be provoked due to the ipecacuanha content of the formulation.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hill’s Balsam Chesty Cough Liquid for Children contains two active ingredients, citric acid monohydrate as a demulcent and ipecacuanha liquid extract as a mild expectorant. Both have been used for many years to promote and facilitate the expulsion of bronchial secretions. Ipecacuanha is thought to have a central action. The vehicle syrup has a demulcent action to soothe an irritating cough.
5.2 Pharmacokinetic properties
Citric acid is absorbed from the gastro-intestinal tract and is oxidised in the body to carbon dioxide and water.
Ipecacuanha Liquid Extract BP contains 1.9 - 2.1% w/v of total alkaloids calculated as emetine. Some emetine is absorbed from the gastrointestinal tract. Cardiovascular effects have been reported. Emetine is also known to accumulate in muscle.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, xanthan gum, saccharin sodium, maltitol syrup, capsicum tincture, compound benzoin tincture, orange oil and potable water.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5
Nature and contents of container
Amber glass (Type III) bottle with ROPP cap or a child resistant closure in pack sizes of 100ml.
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MARKETING AUTHORISATION HOLDER
Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield
West Yorkshire WF2 7BJ United Kingdom
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