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Haleon Cold and Flu Relief All in One 500 mg/100 mg/6.1 mg capsules, hard – patient leaflet, side effects, dosage

Last updated: · Text from the MHRA, as of · About this document

Medicine strength:
500 mg/100 mg/6.1 mg

Patient leaflet - Haleon Cold and Flu Relief All in One 500 mg/100 mg/6.1 mg capsules, hard

1. What Haleon Cold and Flu Relief All in One Capsules are and what they are used for 2.

3.

  1. 4. Possible side effects
  2. 5. How to store Haleon Cold and Flu Relief All in One Capsules
  3. 6. Contents of the pack and other information
  4. 1.

    What Haleon Cold and Flu Relief All in One

    Capsules are and what they are used for

Haleon Cold and Flu Relief All in One Capsules are used for the relief of the symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills and feverishness. They can also loosen stubborn mucus (phlegm) and provide relief from chesty coughs. This medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Guaifenesin is an expectorant which loosens phlegm and relieves a chesty cough. Phenylephrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily.

2. What you need to know before you take Haleon Cold and Flu Relief All in One Capsules

Do not take Haleon Cold and Flu Relief

All in One Capsules

  • if you have ever had an allergic reaction to paracetamol, guaifenesin, phenylephrine

    Paracetamol, Guaifenesin, Phenylephrine Hydrochloride

    ALL IN ONE

    500MG/100MG/6.1MG CAPSULES

    RELIEF

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Cold and Flu

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----62000000216400 if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]), or ergotamine or methylsergide (for migraine), or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants or stimulants; drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin) or if you take blood thinning drugs (anticoagulants e.g. warfarin). Please inform your doctor or pharmacist if you are taking: flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Pregnancy and breastfeeding

Talk to your doctor before taking this product if you are pregnant or breastfeeding.

3. How to take Haleon Cold and Flu Relief All in One Capsules

Adults aged 16 years and over: 2 capsules every four hours as required. Do not take more than 8 capsules (4 doses) in any 24 hour period. Do not give to children under 16 years. • Do not take more frequently than every 4 hours.

  • Do not take more than the recommended dose.
  • Always use the lowest effective dose to relieve your symptoms. • Do not take for more than 5 days without asking your doctor. If you take too many capsules

Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. If symptoms persist, see your doctor.

4. Possible side effects

Like all medicines, Haleon Cold and Flu Relief All in One Capsules can have side effects, but not everybody gets them. Very rare cases of serious skin reactions have been reported. Stop taking this medicine and tell your doctor immediately if you experience:

  • Allergic reactions which may be

    severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath.

  • Skin rash or peeling, or mouth ulcers. • Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin.

    • Unexplained bruising or bleeding. • Reoccurring fevers or infections.
    • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin. • Visual disturbances. This is rare but is more likely in those with glaucoma.
    • Unusually fast pulse rate or sensation of an unusually fast or irregular heartbeat. • Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.

The following side effects may also occur. Tell your doctor if you get them:

  • Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea, sickness or a serious condition that can make blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2). If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme at

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Haleon Cold and Flu Relief All in One Capsules Keep out of the sight and reach of children.

Do not use this medicine after the ‘EXP’ date shown on the pack. Do not store above 25°C.

6. Contents of the pack and other information

Active ingredients Each capsule contains Paracetamol 500 mg, Guaifenesin 100 mg and Phenylephrine Hydrochloride 6.1 mg. Other ingredients maize starch,

croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours quinoline yellow (E 104), indigo carmine (E 132), erythrosine

(E 127) and titanium dioxide (E 171). Pack sizes of 8, 16 and 24 capsules are available Not all pack sizes may be marketed. The marketing authorisation holder is Haleon UK Trading Limited, The Heights, Weybridge, KT13 0NY, U.K.

The manufacturer is Haleon Alcala, S.A., Ctra. de Ajalvir, km. 2500 - 28806 Alcalá de Henares, Madrid - Spain.

This leaflet was revised in February 2025. Trade Marks are owned by or licensed to the Haleon group of companies.

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About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 44673/0230

Last revision stated in the text: February 2025 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Haleon Cold and Flu Relief All in One 500 mg/100 mg/6.1 mg capsules, hard

Active substances Paracetamol, Phenylephrine hydrochloride, Guaifenesin
Strength 500 mg/100 mg/6.1 mg
Pharmaceutical form Dark blue/dark green hard gelatin capsules containing the drug product, an off-white powder.
Excipients Maize starch, Croscarmellose sodium, Sodium laurilsulfate, Magnesium stearate, Talc, Gelatin, Quinoline yellow E104, Indigo carmine E132, Erythrosine E127, Titanium dioxide E171
Shelf life 24 months
Storage Do not store above 25°C
Drug group (ATC) Other analgesics and antipyretics &
  1. N Nervous system drugs
    1. N02 Analgesics
      1. N02B Other analgesics and antipyretics
        1. N02BE Anilide analgesics and antipyretics
          1. N02BE51 paracetamol, combinations excl. psycholeptics
Marketing authorisation PL 44673/0230 (first authorised 22 October 2024)
Marketing authorisation holder Haleon UK Trading Limited

Sources: the MHRA product information (products.mhra.gov.uk). Contains public sector information licensed under the Open Government Licence v3.0.