Država: Malta
Jezik: angleščina
Source: Medicines Authority
ACETIC ACID
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
R05DB
ACETIC ACID 0.42 ml/5ml
ORAL SOLUTION
ACETIC ACID 0.42 ml/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2007-06-12
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Baby Meltus Cough Linctus 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dilute acetic acid BP 0.42ml/5ml 3. PHARMACEUTICAL FORM Syrup for oral use each 5ml containing 0.42ml dilute acetic acid. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For the symptomatic relief of the irritating and distressing coughs which often accompany colds. 4.2 Posology and Method of Administration Oral To be given slowly. 3 months to one year: half a 5ml spoonful. Over one year: one 5ml spoonful. Over 2½ years: two 5ml spoonfuls. Repeat as needed every 2 or 3 hours. 4.3 Contraindications None known. 4.4 Special Warnings Keep out of the reach of children. 4.5 Interaction with Other Medicaments and Other Forms of Interaction None known. 4.6 Pregnancy and Lactation Not applicable. Page 2 of 3 4.7 Effects on Ability to Drive and Use Machines Not applicable. 4.8 Undesirable Effects At the level of acetic acid in this product none are known. 4.9 Overdose Not applicable. Treatment: not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic Properties Baby Meltus Cough Linctus contains acetic acid – a mild expectorant in a sugar free blackcurrant flavoured demulcent base. 5.2 Pharmacokinetic Properties Not applicable. 5.3 Pre-clinical Safety Data Not applicable. 6. PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Tolu flavour solution – sugar free Sorbitol solution non crystallising Carmellose sodium Imitation blackcurrant flavour 500013E Blackcurrant flavour C3688 Sodium sacc Preberite celoten dokument