Leaflet COLDREX NITE 1000mg / 20mg / 15mg syrup


Indicated for: pain; fever

Substance: paracetamol + promethazine + dextromethorphan (analgesic and antipyretic + antihistamine)

ATC: N02BE51 (Nervous system | Other analgesics and antipyretics | Anilides)

Paracetamol, promethazine, and dextromethorphan are active ingredients used in combination to treat symptoms of colds, flu, and dry cough. This combination is effective in reducing fever, calming cough, and alleviating allergic or irritative symptoms of the respiratory tract.

Paracetamol is an analgesic and antipyretic that reduces pain and fever, being well-tolerated by most patients. Promethazine is an antihistamine that helps reduce inflammation and irritation in the respiratory tract, also providing a mild sedative effect that can aid in rest. Dextromethorphan is a cough suppressant that suppresses the cough reflex, making it useful for dry, irritating coughs.

Although this combination is effective, its use should be approached with caution. Promethazine may cause drowsiness, dizziness, or dry mouth, while dextromethorphan may cause dizziness or, in rare cases, sedative-like effects. It is important not to exceed the recommended dose of paracetamol, as it can harm the liver, particularly with long-term use.

This combination is available only by prescription, and its use should be supervised by a doctor. Patients should avoid alcohol consumption during treatment and consult a specialist if symptoms persist or worsen. The treatment is intended for short-term use to relieve acute symptoms.

General data about COLDREX NITE 1000mg / 20mg / 15mg

  • Substance: paracetamol + promethazine + dextromethorphan
  • Date of last drug list: 01-10-2021
  • Commercial code: W67991001
  • Concentration: 1000mg / 20mg / 15mg
  • Pharmaceutical form: syrup
  • Packing volume: 160ml
  • Product type: original
  • Prescription restrictions: OTC - Over the Counter = medicines that do not require a prescription.

Marketing authorisation

  • Manufacturer: WRAFTON LABORATORIES LTD. - MAREA BRITANIE
  • Holder: PERRIGO ROMANIA S.R.L. - ROMANIA
  • Number: 7297/2015/01
  • Shelf life: 3 years;after the first opening of the bottle-6 months