Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Paracetamol 500mg/5ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Paracetamol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Paracetamol Oral Solution contains paracetamol which is a pain-killer and also reduces a fever (high body temperature). This medicine is a higher strength Paracetamol Oral Solution. It is used for mild to moderate pain when you cannot take other paracetamol formulations such as lower strength liquid paracetamol, effervescent tablets or tablets.
What you need to know before you take it
E PARACETAMOL ORAL SOLUTION Do not take Paracetamol Oral Solution:
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
- if you have a liver disorder. Warnings and precautions Talk to your doctor or pharmacist before taking Paracetamol Oral Solution: 1. If you have liver disease, including those due to drinking too much of alcohol. 2. If you have kidney problems. 3. If you are taking or will be taking paracetamol.
During treatment with Paracetamol Oral Solution, tell your doctor straight away if:
- 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). Do not take more than the recommended dose. Children and adolescents This medicine should not be given to children or adolescents under the age of 16 years. Other medicines and Paracetamol Oral Solution Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
- antidepressants, e.g amitriptyline, imipramine
- barbiturates, e.g. phenobarbitone
- anticonvulsants, e.g. carbamazepine, sodium valproate
- metoclopramide (for feeling or being sick)
- domperidone (used to treat heart burn or for feeling or being sick)
- colestyramine (used to treat gall bladder problems and to lower the amount of fat in your blood)
- zidovudine (used in HIV infections and AIDS)
- anticoagulants which are used to prevent blood clotting, e.g. warfarin.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). Some products which can be bought without a prescription may contain paracetamol, so always check the labels for ingredients. Paracetamol Oral Solution with food, drink and alcohol Do not drink alcohol whilst taking Paracetamol Oral Solution. This is because taking alcohol and paracetamol together can increase the risk of liver damage. Pregnancy, breast-feeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for before taking this medicine. If necessary, Paracetamol Oral Solution can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines There are no known effects on the ability to drive and use machines. Paracetamol Oral Solution contains:
- glycerol which may cause headache, stomach upset and diarrhoea
- methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions ( possible delayed)
- propylene glycol: this medicine contains 1530 mg propylene glycol in each 5ml. If you are pregnant or breast‐feeding or suffer from a liver or kidney disease do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine .
- less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'. 3. HOW TO TAKE PARACETAMOL ORAL SOLUTION Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How to take
- this medicine contains 500mg of paracetamol in one 5ml dose
- take this medicine by mouth only
- shake the bottle for at least 10 seconds before use. Make sure the tamper evident seal on the bottle is intact before use. Please use the oral syringe provided to deliver your specific dose (see instructions below). The syringe can be used to measure your dose by drawing the liquid to the correct mark on the syringe.
How to take it
the oral syringe: 1. Shake the bottle well, making sure the cap is firmly on the bottle. 2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use. 3. Push the plastic adapter into the neck of the bottle. 4. Take the syringe and check the plunger is fully down. 5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.
6. Turn the whole bottle with the syringe upside down. 7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up, to completely expel any large air bubble that may be trapped inside the oral syringe. 8. Then pull the plunger slowly back to the volume you need for your dose. 9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle. 10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose. After administration remove the adaptor from the bottle, wash it and allow to dry till you use it the next time. 11. Replace the child proof cap after use.
12. Cleaning: After use, wipe the tip of the syringe with a dry, clean tissue. Do not give this medicine with any other paracetamol containing product. Do not exceed the stated dose. The recommended dose is Adults and young persons 16 years and over 500mg (5ml) to 1000mg (10ml) up to three to four times a day, as required. Maximum daily intake should not exceed 4g (40ml). How often to take
- take a dose of this medicine every 4 to 6 hours when needed
- leave at least 4 hours between doses
- do not take more than 4 doses in 24 hours. Check with your doctor about this. Use in children and adolescents Paracetamol Oral Solution is not recommended for children under 16 years. If you take more Paracetamol Oral Solution than you should You should not take more than 40ml of Paracetamol Oral Solution in 24 hours. 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. Take the remaining solution and this leaflet with you so that the medical staff knows what you have taken. There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur. If you forget to take Paracetamol Oral Solution Do not take a double dose to make up for the forgotten dose. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and you should tell your doctor immediately if you notice the following
- if you experience skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever, sudden wheezing, fluttering or tightness of the chest or collapse
- bruising more easily, sore throat or other signs of infection. This could be because of a blood problem (such as blood dyscrasis including thrombocytopenia and agranulocytosis)
- if you experience severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation).
- if paracetamol is taken for a long time; it may lead to liver and kidney problems
- a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2) (Frequency "Not known").
The following side effects have also been reported: Very rare (may affect up to 1 in 10,000 people)
- very rare cases of serious skin reactions have been reported. These reactions can involve severe rash, blistering and / or redness which may be extensive involving the mucous membranes and large areas of the body. 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 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.
How to store it
PARACETAMOL ORAL SOLUTION
- keep this medicine out of the sight and reach of children
- do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month
- keep this medicine in a dry place
- do not store above 25°C. Do not refrigerate or freeze
- keep the bottle in the outer carton in order to protect from light
- do not use 3 months after you first open it. Take it back to the pharmacy.
- 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 to protect the environment.
Contents of the pack and other information
What Paracetamol Oral Solution contains
- the active substance is paracetamol, 500mg in 5ml
- the other ingredients are citric acid monohydrate, erythrosine (E127), macrogol 400, glycerol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, raspberry flavor No.1, saccharin sodium, sodium citrate, purified water. What Paracetamol Oral Solution looks like and contents of the pack Paracetamol Oral Solution is a clear, pink thick liquid, with the smell of raspberry. It is available in an amber glass bottle with child proof cap packed in an outer box. A plastic dosing syringe (pipette) is also included to help measure the dose. Bottle sizes are 200ml and 300ml. Not all pack sizes may be marketed. Marketing Authorisation Holder Mercury Pharmaceuticals Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufactured By:
Kleva Pharmaceuticals SA 189 Parnithos Ave 13675 – Acharnai, Greece This leaflet was last revised in January 2025.
Frequently asked questions about Paracetamol 500mg/5ml Oral Solution
How do I take Paracetamol 500mg/5ml Oral Solution?
Paracetamol 500mg/5ml Oral Solution comes as oral solution containing 500mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Paracetamol 500mg/5ml Oral Solution?
The active substance in Paracetamol 500mg/5ml Oral Solution is paracetamol.
Are there equivalent medicines to Paracetamol 500mg/5ml Oral Solution?
Medicines with the same active substance, strength and form include: Paracetamol Adult 500mg/5ml Oral Suspension. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Paracetamol 500mg/5ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Paracetamol 500mg/5ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: paracetamol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Paracetamol solution is indicated in the management of pain and fever associated with such conditions as the common cold, influenza and headache.
For patients who are unable to tolerate solid dose formulations or lower strength preparations of paracetamol containing products.
4.2. Posology and method of administration
Posology:
Recommended Doses and Dosage Schedules
Adults and young persons 16 years and over:
The Optimal dosage range is 500mg (5ml) to 1000mg (10ml) up to three to four times a day, as required, to a maximum of 4 g paracetamol/ day (40 ml paracetamol oral solution).
The dose should not be repeated more frequently than every four hours, and not more than four doses should be taken in any 24 hour period.
Elderly:
In older people, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
Paediatric Population
Do not use this medicine in children and adolescents under 16 years.
Method of administration
For oral administration only.
It is important to shake the bottle for at least 10 seconds well before use.
4.3. Contraindications
Hypersensitivity to paracetamol or any of the excipients listed in section 6.1.
Patients with severe hepatic dysfunction.
Do not use this medicine in children and adolescents under 16 years.
4.4. Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non- cirrhotic) alcoholic liver disease.
Do not take with any other paracetamol-containing products.
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment andsepsis or in patients with malnutrition or other sources of gluthione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
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.
Do not exceed the recommended dose.
Keep out of the sight and reach of children.
Excipient warnings:
This product contains the following excipients:
Parahydroxybenzoates: these may cause allergic reactions (possibly delayed).
Propylene glycol: this medicine contains 1530 mg propylene glycol in each 5ml. Therefore, this medicine should be used with caution in pregnancy, breastfeeding, liver or kidney disease.
Glycerol: may cause headache, stomach upset and diarrhoea.
This medicine contains 4.25mg/5ml (0.18 mmol) of sodium which is essentially 'sodium free'.
4.5. Interaction with other medicinal products and other forms of interaction
The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants and alcohol.
Alcohol can increase the hepatotoxicity of paracetamol overdosage.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risk factors. (See section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy:
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Breast-feeding:
Paracetamol is excreted in breast milk but not in clinically significant amount.
Available published data do not contraindicate breast feeding.
Fertility:
There are no data on the effects of this medicine on human fertility.
4.7. Effects on ability to drive and use machines
None known
4.8. Undesirable effects
The information below lists reported adverse reactions, ranked using the following frequency classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse Events
Blood and lymphatic system disorders
Not known
Blood dyscrasia including thrombocytopenia and agranulocytosis1
Immune system disorders
Not known
Anaphylactic shock, angioedema, anaphylactic reaction, urticaria, hypersensitivity, rash
Metabolism and nutrition disorders
Not known
High anion gap metabolic acidosis4
Gastrointestinal disorders
Not known
Acute Pancreatitis2
Skin and subcutaneous disorders
Very Rare
Serious skin reactions
Renal and urinary disorders
Uncommon
Nephropathy toxic3
1But these were not necessarily causally related to Paracetamol.
2Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.
3Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.
4 Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4).
Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has the risk factors.
Risk Factors:
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
OR
b) Regularly consumes ethanol in excess of recommended amounts.
OR
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Hyperglycaemia has been reported. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol; however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote however declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who represent with serious hepatic dysfunction beyond 24h ingestion should be discussed with the NPIS or a liver unit.
💬 Ask about this leaflet
Ask anything about Paracetamol 500mg/5ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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