Patient leaflet - Paracetamol, Ascorbic Acid, Phenylephrine Hydrochloride 750 mg/60 mg/10 mg powder for oral solution
1. What is this medicine and what it is used for
Paracetamol is an analgesic (a painkiller) and antipyretic (it reduces body temperature when you have a fever). Phenylephrine hydrdochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Ascorbic acid (Vitamin C) is a common ingredient of flu and cold products. It is included to help replace the vitamin C which may be lost in the initial stages of flu and colds.
2. What you need to know before you take this medicine
IMPORTANT:
- Do not take with any other Paracetamol-containing products. Do not take with any other flu, cold or decongestant products.
Do not take this medicine if:
- You are allergic to Paracetamol, Ascorbic acid, Phenylephrine hydrochloride or any of the other ingredients listed above.
- You have kidney or liver problems, overactive thyroid, diabetes or are under the care of your doctor for high blood pressure or heart disease.
- You are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or drugs for heart problems (including beta-blockers) or you are taking (or have taken within the last two weeks) drugs called monoamine oxidase inhibitors (MAOIs) prescribed by your doctor or hospital for depression.
- You have glaucoma or Pheochromocytoma
- You have been told by your doctor that you have an intolerance to some sugars; contact your doctor before taking this medicinal product.
Warnings and precautions
During treatment with this medicine, tell your doctor straight away if you have:
Severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
Take special Care with this medicine:
This product may cause dizziness. If affected, do not drive or operate machinery.
Ask your doctor before you take this medicine:
- If you have a blood vessel disease such as Raynaud’s Phenomenon.
- If you have an enlarged prostate.
Contains 2.9 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
This medicine contains 49.047mg sodium (main component of cooking/table salt) in each dosage unit. This is equivalent to 2.452 % of the recommended maximum daily dietary intake of sodium for an adult.
If you are taking other medicines:
Talk to your doctor or pharmacist before taking this medicine if you are taking any prescribed medicines particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick] 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); if you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis talk to your doctor because of the risk of bleeding. But you can still take occasional doses of this medicine at the same time as anticoagulants.
Please inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
If you are pregnant or breast feeding:
Do not take this medicine if you are pregnant or breast feeding unless advised by a doctor.
3. How to take this medicine
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Empty contents of one sachet into a mug. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Adults (including the elderly) and children ages 12 years and over:
The contents of one sachet to be taken every four to six hours as necessary. Do not take more than four sachets in any 24 hours.
Do not give to children under 12 years of age unless your doctor tells you to. Do not take for more than 5 days without asking your doctor If symptoms persist consult your doctor.
If you take more than you should
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.
4. Possible side effects
Like all medicines, this medicine can have side effects but not everybody gets them.
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 and aspirin.
- Unexplained bruising or bleeding.
- 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.
- Usually fast pulse rate or a sensation of an unusually fast or irregular heartbeat
- Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland. These reactions are rare.
The following side effects may occur. Tell your doctor if you get them:
- Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, diarrhoea or sickness.
Not known (frequency cannot be estimated from the available data):
- A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
Reporting of side effects
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
Do not store above 25°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What this medicine contains
- Each 5 g of powder for oral solution contains Paracetamol 750 mg, Ascorbic Acid 60 mg and Phenylephrine Hydrochloride 10 mg as the active ingredients.
- The powder for oral solution also contains sucrose, citric acid, saccharin sodium, sodium citrate, lemon flavours and colour quinoline yellow (E104).
- Sodium content 24.145mg per sachet. Carbohydrate content 2.9 g per sachet.
What this medicine looks like and contents of the pack
Paracetamol, Ascorbic acid, Phenylephrine Hydrochloride 750mg/60mg/10 mg Powder for Oral solution is a pale yellow coloured powder. Each sachet contains 5 g of powder for oral solution. Five or ten sachets are contained in a box.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Thornton and Ross Limited, Linthwaite, Huddersfield, HD7 5QH, UK.
The manufacturer is Haleon Alcala, S.A., Ctra. de Ajalvir, Km 2500, 28806 Alcala de Henares, Madrid, Spain
This leaflet was prepared in March 2025