1. Name Of The Medicinal Product
Junior Meltus Chesty Coughs with Catarrh
2. Qualitative And Quantitative Composition
Guaifenesin 50mg
Cetylpyridinium Chloride 2.5mg
3. Pharmaceutical Form
Oral liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of coughs and catarrh associated with influenza, colds and mild throat infections.
4.2 Posology And Method Of Administration
To be taken three to four times daily.
Children over 6 years: Two 5ml spoonfuls.
Children 2-6 years: One 5ml spoonful
Not to be given to children under two years of age.
Not more than 4 doses should be given in any 24 hours
4.3 Contraindications
This product is contraindicated in patients hypersensitive to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.
4.6 Pregnancy And Lactation
Although there are no known contraindications, as with all medicines, caution should be exercised when administering to pregnant or lactating women.
4.7 Effects On Ability To Drive And Use Machines
Mild drowsiness has been reported.
4.8 Undesirable Effects
Some gastrointestinal discomfort and mild drowsiness has been reported. Very large doses can cause nausea and vomiting.
4.9 Overdose
Very large doses may cause nausea and vomiting. It is, however, rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
A cough linctus containing an expectorant and an oral antiseptic in a colour and sugar free demulcent base, specially formulated for children. The expectorant, guaifenesin, is employed to produce a thinning of mucous secretions and thus relief to bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth infections.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerin
Alcohol 96%
Sorbitol Solution
Menthol
Saccharin Sodium
Sodium Cyclamate
Povidone
Custard Flavour 570514E
Raspberry Flavour 500251E
Blackberry Flavour 500225E
Water
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Store at or below 25oC.
6.5 Nature And Contents Of Container
Amber glass Sirop bottles fitted with tamper evident caps with polycone liner, packed in printed cartons, containing 100ml, 150ml or 200ml linctus.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
Cupal Ltd
Venus,
1 Old Park Lane,
Trafford Park,
Manchester,
M41 7HA,
UK
8. Marketing Authorisation Number(S)
PL 00338/0086.
9. Date Of First Authorisation/Renewal Of The Authorisation
19/06/95
10. Date Of Revision Of The Text
03/2008
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