ACETYLCYSTEINE Powder for oral solution

Active ingredients: Acetylcysteine

Product name and form

Acetylcysteine 200 mg Powder for Oral Solution.

Pharmaceutical Form

Powder for oral solution.

White to slightly pink powder.

Qualitative and quantitative composition

Each sachet contains Acetylcysteine 200 mg.

Excipient(s) with known effect:

Aspartame (E95l): 26 mg per sachet
Sorbitol (E420): 723.34 mg per sachet
Sunset yellow (El10): 0.66 mg per sachet

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Acetylcysteine is N-acetyl derivative of cysteine. Used as a mucolytic agent to reduce the viscosity of mucous secretions.

List of Excipients

Aspartame (E951)
Sorbitol (E420)
Lemon flavour (contains maltodextrin, a form of glucose)
Sunset yellow (E110)

Pack sizes and marketing

Paper/aluminium/polyethylene sachet containing l g powder for oral solution, packaged in a cardboard box, in the following pack sizes: 10, 18, 20, 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield County Durham, NE16 6EA, United Kingdom

Marketing authorization dates and numbers

PL 41344/0057

05/07/2016