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ACETYLCYSTEINE Powder for oral solution (2018)

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.

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
Authorization dates

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

05/07/2016

Marketing authorization number:

PL 41344/0057