Ibuprofen (Nurofen For Children Orange, Nurofen Express, Nurofen, Nurofen Meltlets, Nurofen Soft, Nuroact, Nurofen Liquid, Nurofen Advance Medicated Plaster, Nurofen For Children Strawberry, Nurofen For Children, Nurofen Period Pain)

Ibuprofen

Reckitt Benckinser Pharmaceuticals (Pty) Ltd

S2Read from the PI-PIL document and verified

Registration

Applicant: Reckitt Benckinser Pharmaceuticals (Pty) Ltd
Certificate holder: Reckitt Benckiser Pharmaceuticals (Pty) Ltd
Registrations: 16
Schedule source: SAHPRA documentation

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Nurofen for children orange EACH 5,0 ml SUSPENSION CONTAINS IBUPROFEN 100,0 mg	100 mg per 5 mlSuspension	31046631/2.7/0466Approved 3 September 2025	Registered	Not determined	PI PIL
Nurofen express EACH TABLET CONTAINS IBUPROFEN LYSINATE EQUIVALENT TO IBUPROFEN 200,0 mg	200 mgTablet	34029034/2.7/0290Approved 26 January 2024	Registered	S1	PI PIL
Nurofen caplets EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg	Caplets	35007735/2.7/0077	Registered	Not determined	None
Nurofen meltlets EACH TABLET CONTAINS IBUPROFEN 200,0 mg	Not listed	36002936/2.7/0029	Cancelled	Not determined	None
Nurofen soft gel capsules EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg	Gel capsules	36018436/2.7/0184	Cancelled	Not determined	None
Nurofen gel EACH 1,0 g GEL CONTAINS IBUPROFEN 50,0 mg	Gel	36043336/3.1/0433	Registered	Not determined	None
Nuroact 200mg Each Tablet contains: Sodium Ibuprofen Equivalent to Ibuprofen 200 mg	200mg	43051343/2.7/0513	Cancelled	Not determined	None
Nuroact 400mg Each Tablet contains: Sodium Ibuprofen Equivalent to Ibuprofen 400 mg	400mg	43051443/2.7/0514	Cancelled	Not determined	None
Nurofen liquid capsules 200 EACH CAPSULE CONTAINS :IBUPROFEN 200,0 mg	200Capsules	44038644/2.7/0386	Registered	Not determined	None
Nurofen powder EACH SACHET CONTAINS IBUPROFEN LYSINATE EQUIVALENT TO IBUPROFEN 400,0 mg	Powder	45078145/2.7/0781	Cancelled	Not determined	None
Nurofen liquid capsules 400 Each capsule contains IBUPROFEN 400,0 mg	400Capsules	47028947/2.7/0289	Registered	Not determined	None
Nurofen advance medicated plaster EACH PLASTER CONTAINA IBUPROFEN 200,0 mg	Not listed	55032055/2.7/0320	Registered	Not determined	None
Nurofen for children strawberry EACH 5,0 ml SUSPENSION CONTAINS IBUPROFEN 100,0 mg	100 mg per 5 mlSuspension	A400092A40/2.7/0092Approved 3 September 2025	Registered	Not determined	PI PIL
Nurofen tablets EACH TABLET CONTAINS IBUPROFEN 200 mg	Tablets	S0123S/2.7/123	Registered	Not determined	None
Nurofen for children EACH 5 ml SUSPENSION CONTAINS IBUPROFEN 100,0 mg	200 mg per 5 mlOral suspension.	W0049W/2.7/49Approved 24 January 2025	Cancelled	S2	PI PIL
Nurofen period pain EACH TABLET CONTAINS IBUPROFEN 400 mg	Not listed	W0142W/2.7/142	Registered	Not determined	None

Regulatory status

Where S2 sits on the scale

S0S1S2S3S4S5S6S7S8

A pharmacist can sell it directly, without a prescription.

Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S2, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.

Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Ibuprofen

S4: Ibuprofen
- Ibuprofen, when intended for the treatment of a haemodynamically significant patent ductus arterious in infants less than 34 weeks of gestational age;
- except when contained in preparations intended for application to the skin; containing 5 % m/m or less of ibuprofen; (S0, S1)
- except when contained in transdermal patches containing 200mg of ibuprofen per patch or less, and indicated for use by patients aged 16 years and older (S1)
- except when contained in oral medicinal preparations supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight; (S1)
- except when contained in oral medicinal preparations intended for human use only, in combination with one or more other active therapeutic substances and intended for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 10 days where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
- except when contained in oral medicinal preparations, intended for human use only, as the only active therapeutic substance in oral liquid preparations in packs not exceeding 100 millilitres in volume or in oral solid preparations in packs exceeding 24 dosage units or divided doses, when intended for adults and children over the age of 1 year; for the treatment of mild to moderate pain of inflammatory origin for a maximum treatment period of 10 days, or for the treatment of fever of inflammatory origin or for the treatment of post-traumatic conditions where the recommended daily dose of ibuprofen for adults does not exceed 1,2 grams and for children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
- except for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S2)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 6660 to 6700
S3: Ibuprofen
- when contained in preparations intended for application to the skin, containing 5 % m/m or less of ibuprofen; (S0, S1)
- when contained in transdermal patches containing 200mg of ibuprofen per patch or less, and indicated for use by patients aged 16 years and older (S1)
- when contained in oral medicinal preparations supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight; (S1)
- when contained in oral medicinal preparations intended for human use only, in combination with one or more other active therapeutic substances and intended for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 10 days where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
- when contained in oral medicinal preparations, intended for human use only, as the only active therapeutic substance in oral liquid preparations in packs not exceeding 100 millilitres in volume or in oral solid preparations in packs exceeding 24 dosage units or divided doses, when intended for adults and children over the age of 1 year; for the treatment of mild to moderate pain of inflammatory origin for a maximum treatment period of 10 days, or for the treatment of fever of inflammatory origin or for the treatment of post-traumatic conditions where the recommended daily dose of ibuprofen for adults does not exceed 1,2 grams and for children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
- for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S2)
- when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age. (S4)
Consolidated Schedules 06 July 2026, lines 3734 to 3772
S2: Ibuprofen
- when contained in oral medicinal preparations, intended for human use only in combination with one or more other active therapeutic substances and intended for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 10 days where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight. (S3)
- when contained in oral medicinal preparations, intended for human use only as the only active therapeutic substance in oral liquid preparations in packs not exceeding 100 millilitres in volume or in oral solid preparations in packs exceeding 24 dosage units or divided doses, when intended for adults and children over the age of 1 year; for the treatment of mild to moderate pain of inflammatory origin for a maximum treatment period of 10 days, or for the treatment of fever of inflammatory origin or for the treatment of post-traumatic conditions where the recommended daily dose of ibuprofen for adults does not exceed 1,2 grams and for children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S1, S3)
- for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S3)
- except when contained in preparations intended for application to the skin, containing 5 % m/m or less of ibuprofen; (S0, S1)
- except when contained in transdermal patches containing 200mg of ibuprofen per patch or less, and indicated for use by patients aged 16 years and older (S1);
- except when contained in oral medicinal preparations supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight; (S1)
- except when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age; (S4)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 2126 to 2165
S1: Ibuprofen
- when contained in preparations intended for application to the skin, containing 5 % m/m or less of ibuprofen, and presented in a pack size exceeding 50 grams; (S0)
- when contained in transdermal patches containing 200mg of ibuprofen per patch or less, and indicated for use by patients aged 16 years and older;
- when contained in oral medicinal preparations, intended for human use only, supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight. (S2, S3).
- except when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age; (S4)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 533 to 548

Pharmacological class: Antipyretics or antipyretic and anti-inflammatory analgesics. (class 2.7)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

C₁₃H₁₈O₂206.28 g/mol

2-[4-(2-Methylpropyl)phenyl]propanoic acid

Drag to rotate. Structure from PubChem CID 3672.

SAHPRA documents

Professional information (PI)For healthcare professionals Patient information leaflet (PIL)For patients and carers

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

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