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 120 mg/5 ml Oral Suspension (04917/0009)
⚠ 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 120 mg/5 ml Oral Suspension ("Paracetamol Suspension") contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Suspension can be used in babies and children for the treatment of mild or moderate pain and feverishness associated with teething, toothache, headache, colds and flu. It can also be used in babies who develop fever after vaccination. 2. BEFORE YOU GIVE PARACETAMOL SUSPENSION TO YOUR CHILD DO NOT give Paracetamol Suspension if your child is taking any other paracetamol containing products, other flu, cold, cough or decongestant products, or alcohol. DO NOT give Paracetamol Suspension to your child if he/she:
- is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Suspension (see Section 6 and end of Section 2).
- has kidney or liver problems
- has a rare hereditary problem of fructose intolerance. If you are not sure about any of the above, please consult your doctor. Take special care with Paracetamol Suspension If your child does not get better, talk to your doctor. During treatment with Paracetamol, 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). Taking other medicines Tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicine, even those obtained without a prescription, but especially medicines which:
- are to treat 'flu' or a cold, containing paracetamol and/or a decongestant
- thin the blood (e.g. warfarin)
- control nausea and vomiting (e.g. domperidone or metoclopramide)
- reduce levels of cholesterol and other fats in the blood (e.g. colestyramine)
- treat epilepsy (e.g. anti-convulsants)
- have been prescribed by your doctor to improve sleep (e.g. barbiturates), or for anxiety or depression (e.g. tricyclic antidepressants).
- contain flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). The effects of alcohol may be increased whilst taking Paracetamol Suspension. Avoid alcohol when taking this medicine. Pregnancy and breast-feeding This medicine is intended for use in children. If necessary, Paracetamol Suspension can be used during pregnancy. Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding. 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 if the pain and/or fever are not reduced or if you need to take the medicine more often. Driving and using machines This medicine is intended for use in children. However, it should be noted that Paracetamol Suspension is not expected to affect ability to drive or operate machinery. Important information about some of the ingredients of Paracetamol Suspension Paracetamol Suspension contains:
- Ethanol: This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per dose. (It contains up to 0.08 g of ethanol (alcohol) per 5 ml dose, equivalent to less than 2 ml beer or 1 ml wine per 5 ml dose).
- Hydrogenated glucose syrup (E965): if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
- Amaranth (E123) (colouring): may cause allergic reactions.
How to take it
PARACETAMOL SUSPENSION TO YOUR CHILD Check the tables overleaf to see how much of the medicine to use
- For oral use only
- It is important to shake the bottle for at least 10 seconds before use
- Never give more medicine than shown in the table
- Do not overfill the spoon
- Always use the spoon supplied with the pack
- Do not give anything else containing paracetamol while giving this medicine 23LF02148PW
Babies over 2 months of age For the relief of fever after vaccination at 2, 3 and 4 months 2.5 ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. Age 2-3 months
Dose
Pain and other causes of fever – if your baby weighs over 4 kg and was born after 37 weeks
2.5 ml If necessary, after 4-6 hours, give a second 2.5 ml dose
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. Children aged 3 months – 6 years: Child's Age 3 – 6 months 6 – 24 months 2 – 4 years 4 – 6 years
How Much 2.5 ml 5 ml 7.5 ml (5 ml + 2.5 ml) 10 ml (5 ml + 5 ml)
How often (in 24 hours) 4 times 4 times 4 times 4 times
- Do not give more than 4 doses in any 24 hour period
- Leave at least 4 hours between doses
- Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist If your child takes more of this medicine than they should: Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage. If you forget to give this medicine: If you miss a dose give it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the missed dose.
Possible side effects
Like all medicines, Paracetamol Suspension can cause side effects although not everybody gets them. You or your child may notice the following:
- rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing, which may be signs of an allergic reaction. STOP giving Paracetamol Suspension to your child immediately.
- blood disorders Very rare cases of serious skin reactions have been reported. Frequency "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.
How to store it
PARACETAMOL SUSPENSION Keep all medicines out of sight and reach of children. Do not store above 25 ̊C. Store in the original container. Keep the container in the outer carton. Do not use this medicine after the expiry date which is stated on the label and/or carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Paracetamol Suspension contains Each 5 ml of Paracetamol Suspension contains:
- The active ingredient: paracetamol 120 mg.
- The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, hydrogenated glucose syrup (E965), saccharin sodium (E954), xanthan gum, amaranth (E123), cherry flavour, sodium benzoate (E211), citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information). What Paracetamol Suspension looks like and contents of the pack: Paracetamol Suspension is a pink suspension with cherry odour and taste presented in either:
- 70 ml, 100 ml, 150 ml and 200 ml amber glass bottles with tamper evident and child resistant cap. A 2.5 ml/5 ml measuring spoon is provided.
- 500 ml, 1 litre and 2 litre amber glass bottles with pilfer-proof screw caps or in 500 ml, 1 litre and 2 litre HDPE bottles with tamper evident and child resistant cap. Marketing Authorisation Holder: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland. Product Licence Number: PL 04917/0009 Manufacturers: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, UK. Date of revision: January 2025 23LF02148PW
Frequently asked questions about Paracetamol 120 mg/5 ml Oral Suspension (04917/0009)
How do I take Paracetamol 120 mg/5 ml Oral Suspension (04917/0009)?
Paracetamol 120 mg/5 ml Oral Suspension (04917/0009) comes as oral solution containing 120mg / 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 120 mg/5 ml Oral Suspension (04917/0009)?
The active substance in Paracetamol 120 mg/5 ml Oral Suspension (04917/0009) is paracetamol.
Are there equivalent medicines to Paracetamol 120 mg/5 ml Oral Suspension (04917/0009)?
Medicines with the same active substance, strength and form include: Boots Paracetamol 120 mg/5 ml Oral Suspension (GSL), Boots Paracetamol 120 mg/5 ml Oral Suspension (P), Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension. In total there are 8 equivalent products. 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 120 mg/5 ml Oral Suspension (04917/0009), 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 120 mg/5 ml Oral Suspension (04917/0009) 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
For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.
4.2. Posology and method of administration
Children aged 3 months – 6 years:
Child's Age
How Much
How often
(in 24 hours)
3 – 6 months
2.5 ml
4 times
6 – 24 months
5 ml
4 times
2 – 4 years
7.5ml (5ml + 2.5ml)
4 times
4 – 6years
10ml (5ml + 5ml)
4 times
• Do not give more than 4 doses in any 24 hour period
• Leave at least 4 hours between doses
• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
Babies over 2 months in age
For the relief of fever after vaccination at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
It is important to shake the bottle for at least 10 seconds before use.
4.3. Contraindications
Hypersensitivity to Paracetamol or any of the other constituents.
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.
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 and sepsis, or in patients with malnutrition and other sources of glutathione 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.
The label should contain the following statements:
• Contains paracetamol.
• Do not give this medicine with any other paracetamol-containing product.
• For oral use only.
• Never give more medicine than shown in the table.
• Do not overfill the spoon.
• Always use the spoon supplied with the pack.
• Do not give more than 4 doses in any 24 hour period.
• Leave at least 4 hours between doses.
• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
• If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist (leaflet).
• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.
• Do not store above 25ºC. Store in the original package.
• Keep all medicines out of the sight and reach of children
• Talk to a doctor at once if your child takes too much of this medicine, even if they seem well (label).
• Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage (leaflet).
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Drugs which induce hepatic microsomal enzymes such as alcohol. Concomitant barbiturates and tricyclic antidepressants may increase the hepatoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anti-coagulant 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.
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 risks factors (see section 4.4)
4.6. Pregnancy and lactation
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.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data does not contraindicate breast-feeding.
4.8. Undesirable effects
Very rare cases of serious skin reaction shave been reported. Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported.
SOC: Metabolism and nutrition disorders
“High anion gap metabolic acidosis'' with frequency ''Not known'' (cannot be estimated from the available data)
Description of selected adverse reactions
High anion gap metabolic acidosis
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.
4.9. Overdose
Liver damage is possible in adults who have taken 10 g or more of Paracetamol. Ingestion of 5 g or more of Paracetamol may lead to liver damage if the patient has 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. 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 one 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 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 present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.
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Ask anything about Paracetamol 120 mg/5 ml Oral Suspension (04917/0009). 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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