Junior Meltus Dry Cough with Congestion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

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

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 3.5 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 3.5 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-07-17

Summary of Product characteristics

 
               Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Junior Meltus Dry Coughs with Congestion   
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Dextromethorphan hydrobromide 3.5mg/5ml 
Pseudoephedrine hydrochloride 10mg/5ml 
3 PHARMACEUTICAL 
FORM 
Oral solution 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
An oral solution for the symptomatic relief of
unproductive coughs accompanied by 
congestion of the upper respiratory tract. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
To be given four times a day.  Do not repeat dosage more
frequently 

than every four hours. 
Children 6-12 years: Two 5ml spoonfuls 
Children 2-5 years: One 5ml spoonful 
Adults, the elderly and children over 12 years are recommended
to take Adult Meltus Dry 
Coughs with Congestion.  Not to be given to children under
two years of age. 
4.3 CONTRA-INDICATIONS 
Junior Meltus Dry Coughs with Congestion is contraindicated in 
patients with a known 
hypersensitivity to pseudoephedrine or dextromethorphan.
 Contraindicated in persons under 
treatment with monoamine oxidase inhibitors or within 2 weeks
of stopping such treatment.  
Contraindicated in patients with severe hypertension or
severe coronary artery disease. 
Junior Meltus Dry Coughs with Congestion should
not be administered to patients where the 
cough is associated with asthma or where the cough is
accompanied by excessive secretions. 
Dextromethorphan,
in common with other centrally acting antitussive
agents, should not be 
given in or at risk of developing respiratory failure.
 Although pseudoephedrine has virtually 
no pressor effect in patients with normal blood pressure,
Junior Meltus Dry Coughs with 
Congestion should be used with caution in patients taking
hypertensive agents, tricyclic 
antidepressants, other sympathomimetic agents, such
as decongestants, appetite suppres