Full Prescribing Info
Ambroxol HCl.
AMXOL TABLETS: Each tablet contains: Ambroxol HCl 30 mg.
AMXOL SYRUP: Each 5 ml contains: Ambroxol HCl 30 mg.
AMXOL (Ambroxol Hydrochloride) is a metabolite of bromhexine, which liquefies and changes the structure of bronchial secretions. By this ways it promotes the expectoration of blocked-up secretions and also eases cough.
Acute and chronic diseases of the respiratory tract, especially in chronic bronchitis, asthmatoid bronchitis, bronchial asthma, bronchiectasis, laryngitis, sinusitis. Ambroxol hydrochloride reduces the viscosity of the sputum.
Dosage/Direction for Use
AMXOL TABLETS: Adults and children over 6 years: 1 tablet three times daily at the beginning of treatment.
In long term therapy the dose may be reduced to 1 tablet twice daily.
The tablets should be taken after meals.
AMXOL SYRUP: Adults: 1 teaspoonful (30 mg), 3 times daily.
Children over 5 years: ½ teaspoonful (15 mg), 2-3 times daily.
Children 2 to 5 years: ¼ teaspoonful (7.5 mg), 3 times daily.
The daily dose may be increased or doubled if necessary.
For long term treatment the dose may be reduced.
The dosage recommendations for children are based on a total daily dose of 1.2 to 1.6 mg of Ambroxol per kg body weight.
No symptoms of overdosage have been reported. Should they occur, symptomatic treatment should be provided.
AMXOL is recommended not to prescribe during the first trimester of pregnancy.
Warning for Metabisulfite: Following oral ingestion, sodium metabisulfite is oxidized to sulfate and is excreted in the urine. Ingestion may result in gastric irritation due to liberation of sulfurous acid, while ingestion of large amounts of sodium metabisulfite can cause gastro-intestinal upsets, circulatory failure and central nervous system disturbances.
Special Precautions
Patients being treated with AMXOL should be warned to expect an increase in the flow of secretions.
Use In Pregnancy & Lactation
AMXOL is recommended not to prescribe during the first trimester of pregnancy.
Adverse Reactions
Occasional gastrointestinal side effects may occur but these are almost invariably mild.
Store in a cool dry place at temperature not exceeding 30°C.
AMXOL TABLETS: Protect from light and moisture.
AMXOL SYRUP: Protect from light and excessive heat.
Shelf-Life: AMXOL TABLETS: The shelf-life period is 5 years.
AMXOL SYRUP: The shelf-life period is 3 years.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Tab (round, flat, white, bisected on one face and impressed BIOLAB's logo on the obverse) 30 mg x 50 x 10's. Syr (clear colorless pear-flavored solution) 30 mg/5 mL x 60 mL.
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