Menthodex Cough Mixture

Country: Malta

Language: English

Source: Medicines Authority

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Active ingredient:

AMMONIUM CHLORIDE, TOLU TINCTURE, TUSSILAGO FARFARA, MARRUBIUM VULGARE, MENTHOL, SODIUM CITRATE, SQUILL TINCTURE

Available from:

Bell Sons & Co. (Druggists) Limited Gifford House, Slaidburn Crescent, Southport, Mersyside PR 9 9AL, United Kingdom

ATC code:

R05CA

INN (International Name):

AMMONIUM CHLORIDE 100 mg/5ml TOLU TINCTURE 0.001 ml/5ml TUSSILAGO FARFARA 0.0004 ml/5ml MARRUBIUM VULGARE 0.0015 ml/5ml MENTHOL 7.75 mg/5ml SODIUM CITRATE 50 mg/5ml SQUILL TINCTURE 0.001 ml/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

AMMONIUM CHLORIDE 100 mg/5ml TOLU TINCTURE 0.001 ml/5ml TUSSILAGO FARFARA 0.0004 ml/5ml MARRUBIUM VULGARE 0.0015 ml/5ml MENTHOL 7.75 mg/5ml SODIUM CITRATE 50 mg/5ml SQUILL TINCTURE 0.001 ml/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-05-31

Summary of Product characteristics

                                Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
PRODUCT SUMMARY 
 
1. 
NAME OF THE MEDICINAL PRODUCT 
 
 
Menthodex Cough Mixture 
              
 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
 
Each 5ml contains 
 
 
Ammonium Chloride BP 
 
100 mg 
 
Sodium Citrate BP 
 
 
50 mg 
             Menthol BP  
 
7.75 mg 
             Liquid Extract of Horehound   
0.0015 ml 
             Tolu Tincture BPC 1959 
 
0.001 ml 
             Squill Tincture BP 1980 
 
0.001 ml 
 
Liquid Extract of Tussilago    
0.0004 ml 
         
     
 
3. PHARMACEUTICAL 
FORM 
 
 
 Oral 
liquid 
 
 
4. 
CLINICAL PARTICULARS 
 
4.1 THERAPEUTIC 
INDICATIONS 
 
For the symptomatic relief of colds, sore throats, irritating and
chesty coughs. 
 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
 
 Oral 
administration 
 
Adults: two 5 ml spoonfuls 
 
Children (7-14 years):  One 5 ml spoonfuls 
 
Dose may be repeated three times a day and at bedtimes 
 
4.3 CONTRA-INDICATIONS 
 
Care should be taken when given to patients with impaired
renal function or hypersensitivity to  
any of the active ingredients. 
 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
 
 
Shake bottle.  
 
If symptoms persist consult your doctor.  
 
Page 2 of 3 
4.5 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION 
 
 None 
known 
 
4.6 PREGNANCY 
AND 
LACTATION 
 
No evidence that this medicine adversely
affects pregnancy, however, as with all medicines it is 
recommended that Menthodex is not taken during pregnancy.  
 
4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 
 
 None 
 
4.8 UNDESIRABLE 
EFFECTS 
 
 
Nausea and vomiting have
been reported on taking large doses of some ingredients. 
 
4.9 OVERDOSE 
 
 
It is possible that excessive overdosing may produce nausea
and vomiting. If this 
                                
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