Baby Meltus Cough Linctus

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACETIC ACID

Available from:

Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom

ATC code:

R05DB

INN (International Name):

ACETIC ACID 0.42 ml/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

ACETIC ACID 0.42 ml/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-06-12

Summary of Product characteristics

 
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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