Leaflet COLDREX SINUMAX COLD AND COUGH 1000mg / 200mg / 12.2mg powder for oral solution


Indicated for: cold and flu symptoms

Route of administration: oral

Substance: paracetamol + guaifenesin + phenylephrine (analgesic and antipyretic + expectorant + adrenergic decongestant)

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

Precautions:
Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Paracetamol, guaifenesin, and phenylephrine are active ingredients used in combination to treat cold and flu symptoms such as fever, headaches, nasal congestion, and productive cough. This combination is commonly used to provide comprehensive relief from respiratory symptoms and associated discomfort.

Paracetamol is an analgesic and antipyretic that reduces pain and fever, being well-tolerated by most patients. Guaifenesin is an expectorant that helps thin mucus, making it easier to expel through coughing. Phenylephrine is a nasal decongestant that works by constricting blood vessels in the nasal mucosa, reducing inflammation and congestion.

Although this combination is effective, its use should be approached with caution. Phenylephrine may cause side effects such as increased blood pressure, insomnia, or agitation, especially in sensitive individuals. Guaifenesin may cause nausea or stomach discomfort, and paracetamol, if overused, can harm the liver.

This combination is available over the counter, but patients should follow the recommended dosage and avoid long-term use. If symptoms persist for more than a few days or worsen, medical advice is necessary. Individuals with high blood pressure or other chronic conditions should consult a doctor before use.

General data about COLDREX SINUMAX COLD AND COUGH 1000mg / 200mg / 12.2mg

  • Substance: paracetamol + guaifenesin + phenylephrine
  • Date of last drug list: 01-09-2022
  • Commercial code: W69080001
  • Concentration: 1000mg / 200mg / 12.2mg
  • Pharmaceutical form: powder for oral solution
  • Quantity: 5
  • Product type: generic
  • Prescription restrictions: OTC - Over the Counter = medicines that do not require a prescription.

Marketing authorisation

  • Manufacturer: OMEGA PHARMA INTERNATIONAL NV - BELGIA
  • Holder: PERRIGO ROMANIA S.R.L. - ROMANIA
  • Number: 14310/2022/01
  • Shelf life: 3 years-after packing for marketing;after reconstitution-30 minute

Pharmaceutical forms available for paracetamol + guaifenesin + phenylephrine

Concentrations available for paracetamol + guaifenesin + phenylephrine

  • 1000mg/200mg/12.2mg
  • 125mg/50mg/2.5625mg
  • 250mg/100mg/5mg
  • 500mg/100mg/5mg
  • 500mg/200mg/10mg