FLAVAMED HUSTENSAFT Oral solution Ref.[6243] Active ingredients: Ambroxol

Source: European Medicines Agency (EU)  Revision Year: 2016 

Product name and form

Flavamed Hustensaft 15 mg/5 ml oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless to slightly brownish liquid with a fruity odour of raspberry.

Qualitative and quantitative composition

1 ml of oral solution contains 3 mg ambroxol hydrochloride.

One measuring spoon with 5 ml of oral solution contains 15 mg ambroxol hydrochloride.

Excipients with known effect: Sorbitol 1.75 g/5 ml oral solution (see section 4.4 and 6.1)

For the full list of excipients, see section 6.1.

Active Ingredient Description

Ambroxol induces activation of the surfactant system by acting directly on the type II pneumocytes of the alveoles and the Clara cells in the region of the small airways. It promotes the formation and outward transfer of surface-active material in the alveolar and bronchial region of the foetal and adult lungs.

List of Excipients

Sorbitol, liquid non-crystallising (E420)
Benzoic acid
Glycerol 85 per cent
Raspberry flavouring
Purified water

Pack sizes and marketing

Amber glass bottle (glass type III) with a screw cap, a tamper evident closure and a measuring spoon

The screw cap is made from polypropylene. Colour concentrate white serves as colouring agent.

A 5 ml measuring spoon with ¼ and ½ graduation is part of the product. The measuring spoon is made from polypropylene.

Pack sizes:

  • 1 × 60 ml of oral solution
  • 1 × 100 ml of oral solution

Not all pack sizes may be marketed.

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