Junior Meltus Chesty Coughs with Catarrh

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CETYLPYRIDINIUM CHLORIDE, GUAIFENESIN

Available from:

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

ATC code:

R05DA09

INN (International Name):

CETYLPYRIDINIUM CHLORIDE 2.5 mg GUAIFENESIN 50 mg

Pharmaceutical form:

ORAL LIQUID

Composition:

CETYLPYRIDINIUM CHLORIDE 2.5 mg GUAIFENESIN 50 mg

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-07-12

Summary of Product characteristics

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF MEDICINAL PRODUCT 

Junior Meltus Chesty Coughs with Catarrh 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Guaiphenesin 50 mg 
Cetylpyridinium Chloride 2.5 mg 

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 

To be taken three to four times daily. 
_Children over 6 years_:  Two 5 ml spoonfuls 
_Children 1-6 years_: 

One 5 ml spoonful 
_Children under 1 year_:  Not recommended unless on medical
advice. 

4.3 CONTRAINDICATIONS 

This product is contraindicated in patients hypersensitive to any of
the ingredients. 

4.4  SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Children under 1 year of age - this product should only be
administered with medical advice. 

4.5  INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS
OF INTERACTION 

Can cause transient abnormality in platelet aggregation patterns
determined one hour after 
ingestion.  

4.6  PREGNANCY AND LACTATION 

Although there are no known contra-indications, as with
all medicines caution should be 
exercised when administering to pregnant or lactating women. 

4.7  EFFECTS ON ABILITY TO DRIVE AND TO USE MACHINES 

Mild drowsiness has been reported. 

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4.8 UNDESIRABLE 
EFFECTS 

Some gastro-intestinal discomfort and mild drowsiness has been
reported.  Very large doses 
can 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 cou