A
1. Name Of The Medicinal Product
Adult Meltus for Chesty Coughs and Catarrh.
2. Qualitative And Quantitative Composition
Guaifenesin 100mg / 5ml
Cetylpyridinium Chloride 2.5mg / 5ml
Sucrose 1.75g / 5ml
Purified Honey 0.5g / 5ml
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
Oral.
Adults and children over 12 years:
One or two 5ml spoonfuls to be taken and swallowed slowly every three or four hours. Not recommended for children under 12 years.
4.3 Contraindications
No known contraindications.
4.4 Special Warnings And Precautions For Use
Not suitable for children under 12 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
No known contraindications.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Some gastrointestinal discomfort. Very large doses may 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 honey and syrup demulcent base. The expectorant, guaifenesin, is employed to produce a thinning of mucous secretions and thus gives relief in bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth and throat infections.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerin
Alcohol (96%)
Aniseed oil
Menthol crystals
Chloroform
Caramel (E150)
Glucose Liquid
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf Life
Five years.
6.4 Special Precautions For Storage
Store below 25oC.
6.5 Nature And Contents Of Container
Glass amber sirop bottle with tamper evident cap with fitted ploycone liner in an individual carton containing 100ml or 200 ml of product, including a 5ml CE marked polystyrene measuring spoon.
6.6 Special Precautions For Disposal And Other Handling
No special requirements
7. Marketing Authorisation Holder
Cupal Limited, Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA
8. Marketing Authorisation Number(S)
PL 0338/5026R
9. Date Of First Authorisation/Renewal Of The Authorisation
14/09/90 / 07/09/99
10. Date Of Revision Of The Text
July 2006
Adult Meltus for Chesty Coughs and Catarrh
.