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HSA Approval

NUROFEN FOR CHILDREN 200MG/5ML

SIN14958P

NUROFEN FOR CHILDREN 200MG/5ML

NUROFEN FOR CHILDREN 200MG/5ML

February 19, 2016

RECKITT BENCKISER (SINGAPORE) PTE LTD

RECKITT BENCKISER (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantRECKITT BENCKISER (SINGAPORE) PTE LTD
Licence HolderRECKITT BENCKISER (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

SYRUP

**HOW SHOULD NUROFEN FOR CHILDREN BE GIVEN?** Shake the bottle well before measuring the dose. **For pain and fever:** The daily dosage of Nurofen for Children Orange Sugar Free is 20–30mg/kg body weight in divided doses to be taken with or after food: **Children 6–9 years:** 5.0ml may be taken three times daily in 24 hours. **Children 10–12 years:** 7.5ml 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 between each dose if recommended by doctor. For short-term use only. If the child’s symptoms persist for more than 3 days, consult your doctor. If you are an adult taking this product, speak to your pharmacist or doctor before taking if: - You are pregnant - You are trying to get pregnant - You are elderly - You are a smoker If symptoms persist for more than 3 days, consult your doctor.

ORAL

Medical Information

**WHAT IS IT FOR?** Nurofen for Children is suitable for children from 6 years old weighing more than 20kg, 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 throat, headache, 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 child if: - They have had an allergic reaction to ibuprofen or any of the ingredients in the product - They have previously had worsening of asthma, itchy, runny nose, allergic rash or hives in response to aspirin or other non-steroidal anti-inflammatory drugs - They have or ever had a stomach ulcer - They have or ever had upper gastrointestinal bleeding or perforation, after having NSAIDs

M01AE01

ibuprofen

Manufacturer Information

RECKITT BENCKISER (SINGAPORE) PTE LTD

Reckitt Benckiser Healthcare (UK) Limited

Active Ingredients

Ibuprofen

200mg/5mL

Ibuprofen

Documents

Patient Information Leaflets

NUROFEN FOR CHILDREN 200MG5ML PIL.pdf

Approved: January 4, 2022

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