Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, SUGAR COATED
**Recommended Dose** For oral administration and short-term use only. During short-term use, if symptoms persist or worsen, the patient should be advised to consult a doctor. Adult and children over 12 years: The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, the patient should consult a doctor. Take 1 tablet with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 3 tablets in any 24 hour period. Not for use by children under 12 years of age.
ORAL
Medical Information
**Indications** Nurofen relieves pain such as headache, migraine, dental pain, period pain, rheumatic pain, muscular pain and backache. Nurofen relieves fever such as fever associated with cold and flu.
**Contraindication** Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure, renal failure or hepatic failure (see Special warning and precaution for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularization procedures. Last trimester of pregnancy (see Pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
M01AE01
ibuprofen
Manufacturer Information
RECKITT BENCKISER (SINGAPORE) PTE LTD
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
Active Ingredients
Documents
Package Inserts
Nurofen Tablet 400mg PI.pdf
Approved: October 18, 2021