SPC: FLAVAMED HUSTENSAFT Oral solution (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.

List of excipients

Sorbitol, liquid non-crystallising (E420)
Benzoic acid
Glycerol 85 per cent
Hydroxyethylcellulose
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.

Marketing authorization holder
Authorization dates
Marketing authorization number: