Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SYRUP
**HOW SHOULD NUROFEN FOR CHILDREN BE GIVEN?** READ THE LEAFLET CAREFULLY BEFORE USE. Shake the bottle well before measuring the dose. Do not give to babies under 6 months or babies weighing less than 5kg. **For post-immunisation fever:** Can be given to babies from 6 months old on the advice of the doctor. Initial dose of 2.5mL followed by a further 2.5mL 6 hours later if necessary. No more than 5.0mL in 24 hours. If the fever is not reduced, consult your doctor. **For pain and fever:** The daily dosage of Nurofen For Children is 20–30mg/kg body weight in divided doses to be taken with or after food: **Babies 6–12 months:**2.5mL may be taken three to four times daily in 24 hours.**Children 1–3 years:**5.0mL may be taken three times daily in 24 hours.**Children 4–6 years:**7.5mL may be taken three times daily in 24 hours.**Children 7–9 years:**10.0mL may be taken three times daily in 24 hours.**Children 10–12 years:**15.0mL may be taken three times daily in 24 hours. 1 teaspoon = 5.0mL. Do not exceed the stated dose. Doses should be given every 6–8 hours as necessary or with a minimum of 4 hours if recommended by doctor. **For short-term use only.** If the child’s (aged 6 months and over) symptoms persist for more than 3 days, consult your doctor. For children under 6 months, medical advice should be sought.
ORAL
Medical Information
**WHAT IS IT FOR?** Nurofen For Children is suitable for most babies and children from 6 months, to be given orally. Nurofen For Children is indicated for the reduction of fever (including that associated with immunization), and the relief of pain from teething, toothache, earache, sore throats, minor aches and sprains. Your doctor may prescribe this medicine for other conditions; follow his/her instruction on how often and how much to give your child.
**CHECK BEFORE YOU TAKE THIS PRODUCT:** Nurofen For Children should not be given to your baby or child if: - They experience symptoms of dengue fever (e.g. high fever, severe headache, muscle and joint pains). - They had an allergic reaction to aspirin, ibuprofen, other NSAID medicine or any of the ingredients listed above – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - They are taking other NSAID pain killers (e.g. ibuprofen, naproxen, diclofenac), or aspirin with a daily dose above 75mg. - They have had a worsening of asthma, allergic rash or an itchy, runny nose when taking ibuprofen, aspirin or other NSAID medicines. - They have or have ever had a stomach ulcer, perforation or bleeding. - They have severe kidney, heart or liver failure. - They weigh less than 5kg or are under 6 months of age.
M01AE01
ibuprofen
Manufacturer Information
RECKITT BENCKISER (SINGAPORE) PTE LTD
RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD
Active Ingredients
Documents
Patient Information Leaflets
NUROFEN FOR CHILDREN 100 mg5 ml (OTC Pack) PIL.pdf
Approved: January 4, 2022