Sunday, January 10, 2010


Ambroxol hydrochloride

Each tablet contains 30 mg
5 ml syrup contains 30 mg
5 ml syrup contains 15 mg
1 ml drops for oral use contains 15 mg
Ambroxol hydrochloride

Ambroxol is a mucolytic agent, which is able to ease the thick and sticky fluid secretion from respiratory tract.

As mucolytic in acute and chronic respiratory tract diseases particularly in chronic bronchitis exacerbation and bronchitis asthmatic and bronchial asthma.

Hypersensitivity to Ambroxol.

Ambroxol can be administered during the pregnancy (especially in the first trimester) and lactation only after careful risk/benefit assessment. Administration during pregnancy and lactation still needs further research. Ambroxol should not be used in the long term without doctor's advice/consultation.
In some cases of renal insufficiency, accumulation of Ambroxol metabolites takes place in the liver.

Side Effects
  • Intolerance reactions after Ambroxol administration have been reported in rare cases.
  • Mild gastro-intestinal side effects have been reported in some patients.
  • Allergic reactions have been reported in rare cases and some of these patients have also shown allergic reactions to other substances.
    Some of allergic reactions are: skin rashes, swelling of face, dyspnoea, fever.
  • It is not known whether Ambroxol has impact to ability of driving or operating machinery.
Drug Interactions
Administration of Ambroxol together with antibiotics (Amoxicillin, Cefuroxime, Erythromycin, Doxycycline) leads to higher antibiotic concentration in the lung tissue.

Dosage and Administration
Tablet 30 mg:
Adult and children above 12 years 1 tablet 2 - 3 times daily
Children 6-12 years 1/2 tablet 2-3 times daily

Syrup 30 mg/5ml:
1 measuring spoonful = 5 ml
Adult and children above 12 years 5 ml (1 msp.) 2-3 times daily
Children 6-12 years 2.5 ml (1/2 msp.) 2 - 3 times daily

Syrup 15 mg/5ml:
Children 6-12 years 5 ml (1 msp.) 2-3 times daily
Children 2-6 years 2.5 ml (1/2 msp.) 3 times daily
Children under 2 years 2.5 ml (1/2 msp.) 2 times daily

Drops 15 mg/ml (1ml = 20 drops):
Children ≤ 2 years 0.5 ml (10 drops) 2 times daily
Ambroxol Drops is recommended to take with meals possibly diluted with tea, fruit, milk or water.

Tablet 30 mg: Box contains of 10 strips@ 10 tablet Reg. No. DKL0133702210A1
Syrup 30 mg/5ml: Bottle of 60 ml Reg. No. DKL0133701837B1
Syrup 15 mg/5ml: Bottle of 125 ml & 60 ml Reg. No. DKL0133701837A1
Drops for oral use 15 mg/ml: Bottle of 20 ml Reg. No. DKL0133702336A1

Manufactured by:
PT. Boehringer lngelheim Indonesia
Bogor, Indonesia

Under license from:
Boehringer lngelheim International GmbH
Ingelheim am Rhein

Store in 25-30°C, protect from light.
Store in a safe place, out of the reach of children.
Only on doctor's prescription
Harus dengan resep dokter


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