Nurofen for Children Cold, Pain & Fever Strawberry Flavour 100ml is an ibuprofen 100mg/5ml oral suspension for relieving mild to moderate pain and reducing fever in babies and children.

The medicine contains ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce high temperatures. It is used for the relief of cold and flu symptoms, sore throats, headaches, teething pain, toothache, minor muscular aches and sprains, as well as fever, including fever following immunisation.

This strawberry-flavoured liquid is suitable for babies aged 3 months and over who weigh more than 5kg, and children, when used according to the recommended dosage instructions.

Each 100ml bottle includes a dosing syringe to help measure and administer the correct amount of medicine. The liquid formulation allows dosing according to the child's age and provides an alternative to solid tablets.

For short-term use only. Always follow the recommended dosage and seek medical advice if symptoms persist or worsen.

Patient Information Leaflet

Main ingredients: Ibuprofen 100mg per 5ml of oral suspension (20mg/ml).

Excipients: Maltitol liquid, purified water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharin, strawberry flavour (containing propylene glycol (E1520) and ascorbic acid (E300)), xanthan gum, polysorbate 80, domiphen bromide.

Nurofen for Children Cold, Pain & Fever Strawberry Flavour is intended for short-term relief of fever, including post-immunisation fever, cold and flu symptoms, and mild to moderate pain, including headaches, sore throats, teething pain, toothache, minor aches and sprains.

Dosage for fever, pain and symptoms of cold and flu:

• Babies aged 3–6 months (weighing over 5kg): Give 2.5ml up to 3 times in 24 hours. Do not use for longer than 24 hours.
• Babies aged 6–12 months: Give 2.5ml up to 3 or 4 times in 24 hours.
• Children aged 1–3 years: Give 5ml up to 3 times in 24 hours.
• Children aged 4–6 years: Give 7.5ml up to 3 times in 24 hours.
• Children aged 7–9 years: Give 10ml up to 3 times in 24 hours.

For post-immunisation fever:

For babies aged 3 months and over weighing more than 5kg, give 2.5ml, followed by one further 2.5ml dose after 6 hours if necessary.

Do not give more than two 2.5ml doses within 24 hours for post-immunisation fever. If the fever does not improve, consult a doctor.

How to administer:

1. Shake the bottle thoroughly before each use.
2. Open the child-resistant cap by pressing down and turning anticlockwise.
3. Insert the supplied dosing syringe firmly into the bottle opening.
4. Turn the bottle upside down and draw the required amount into the syringe.
5. Return the bottle to an upright position and remove the syringe.
6. Place the syringe into the child's mouth and slowly release the medicine.
7. Replace the bottle cap securely. Wash the syringe in warm water and allow it to dry.

Important dosing instructions:

• Give doses approximately every 6–8 hours, leaving at least 4 hours between doses.
• Do not exceed the recommended number of doses in any 24-hour period.
• Do not give to babies younger than 3 months or weighing less than 5kg.
• Use the lowest effective dose for the shortest period necessary.
• For children with sensitive stomachs, the medicine may be given with or after food.

Duration of use:

For babies aged 3–6 months, do not use for more than 24 hours. Consult a doctor if symptoms persist or worsen.

For children aged 6 months and over, do not use for more than 3 days without medical advice. Consult a doctor if symptoms persist or worsen.

If your child has an infection and symptoms such as fever or pain persist or worsen, seek medical advice without delay.

Missed dose: Give the next dose when needed, provided at least 4 hours have passed since the previous dose. Do not give a double dose.

Overdose: If more than the recommended amount has been given, contact a doctor or the nearest hospital immediately, even if no symptoms are present.

Do not give Nurofen for Children Cold, Pain & Fever Strawberry Flavour if your child:

• Is allergic to ibuprofen, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the ingredients.
• Has previously experienced asthma, a runny nose, a rash or swelling of the face, tongue, lips or throat after taking aspirin, ibuprofen or another NSAID.
• Is under 3 months of age or weighs less than 5kg.
• Is taking another NSAID or aspirin at doses above 75mg daily.
• Has or has previously had two or more episodes of stomach ulcers, bleeding or perforation.
• Has experienced stomach bleeding or perforation associated with previous NSAID use.
• Has severe kidney, liver or heart failure.
• Has hereditary fructose intolerance, because this medicine contains maltitol.

Warnings and precautions

Speak to a doctor or pharmacist before use if your child:

• Has asthma or another allergic condition affecting the lungs.
• Has or has previously had high blood pressure, heart problems or a stroke.
• Has diabetes or high cholesterol.
• Has liver, kidney, heart or bowel problems.
• Is dehydrated, as ibuprofen may increase the risk of kidney problems.
• Has systemic lupus erythematosus (SLE) or another connective tissue disorder.
• Has Crohn's disease or ulcerative colitis.
• Has an infection that is persisting or worsening.

Avoid using ibuprofen during chickenpox (varicella) because of the risk of serious skin and soft tissue complications.

Ibuprofen may temporarily hide signs of infection, including fever and pain. If symptoms of an infection persist or worsen, consult a doctor without delay.

Pregnancy and breastfeeding

This medicine is primarily intended for children, but the following precautions apply if it is being considered for adult use.

Pregnancy: During the first six months of pregnancy, ibuprofen should only be taken if absolutely necessary and advised by a doctor. Use the lowest dose for the shortest possible period.

From 20 weeks of pregnancy, use for more than a few days may cause kidney problems in the unborn baby, reduced amniotic fluid or narrowing of a blood vessel in the baby's heart.

Do not take ibuprofen during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery.

Breastfeeding: If breastfeeding, seek medical advice before taking this medicine. Limited studies indicate that ibuprofen passes into breast milk in very low concentrations and is unlikely to adversely affect the breastfed infant.

Fertility: Ibuprofen may temporarily affect female fertility. This effect is reversible after stopping the medicine.

Interactions with other medicines

Tell your doctor or pharmacist if your child is taking other medicines, particularly:

• Aspirin, including low-dose aspirin.
• Other medicines containing ibuprofen or other NSAIDs.
• Anticoagulants, such as warfarin.
• Antiplatelet medicines, including clopidogrel.
• Medicines for high blood pressure.
• Diuretics.
• Corticosteroids.
• Selective serotonin reuptake inhibitor (SSRI) antidepressants.
• Lithium.
• Methotrexate.
• Cardiac glycosides.
• Ciclosporin or tacrolimus.
• Zidovudine.
• Mifepristone.
• Quinolone antibiotics.

This is not a complete list of possible interactions.

Important ingredient information

• Maltitol: Contains approximately 2.23g of maltitol per 5ml. It may have a mild laxative effect and is unsuitable for people with hereditary fructose intolerance.
• Propylene glycol: Contains 11.75mg per 5ml of oral suspension.
• Sodium: Contains less than 1mmol (23mg) of sodium per dose, making it essentially sodium-free.

Serious allergic and skin reactions

Stop using this medicine and seek immediate medical attention if your child develops:

• Swelling of the face, tongue, lips or throat.
• Breathing difficulties, wheezing or severe asthma symptoms.
• Chest pain associated with an allergic reaction.
• Widespread skin rashes, blistering, skin peeling or sores affecting the mouth or eyes.
• A rash accompanied by fever or swollen lymph nodes.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome and acute generalised exanthematous pustulosis, have been reported with ibuprofen.

Driving and drowsiness

No effects on driving or operating machinery are expected at recommended doses and treatment durations. However, dizziness or drowsiness may occur, particularly following excessive doses.

Overdose

Taking more than the recommended amount can cause nausea, vomiting, stomach pain, ringing in the ears, confusion, dizziness, drowsiness, seizures and other serious complications.

If an overdose occurs, contact a doctor or the nearest hospital immediately, even if no symptoms are present.

Storage and safety

• Keep out of the sight and reach of children.
• Store below 25°C.
• Do not use after the expiry date printed on the packaging.
• Do not exceed the recommended dose or duration of use.

Always read the Patient Information Leaflet before use.

Like all medicines, Nurofen for Children Cold, Pain & Fever Strawberry Flavour can cause side effects, although not everybody experiences them.

The most frequently reported problems involve the digestive system, including stomach irritation, indigestion and heartburn.

Serious side effects requiring urgent medical attention

Stop giving this medicine and seek urgent medical advice if your child experiences any of the following:

Other side effects requiring medical advice

Contact a doctor if your child experiences unexplained stomach pain, persistent indigestion, heartburn, nausea, vomiting or diarrhoea.

Do not continue giving the medicine if a serious side effect is suspected.

Side effects can be reported through the MHRA Yellow Card Scheme. Speak to a doctor or pharmacist if any side effects occur or if you are concerned about your child's reaction to the medicine.