Ibuprofen (Brufen Sugar-free, Brufen, Brufen Rapid, Brufen Extra Strength, Brufen For Children, Brufen Retard, Brufen Ds)
Ibuprofen
Abbott Laboratories S.A. (Pty) Ltd
Registration
- Applicant
- Abbott Laboratories S.A. (Pty) Ltd
- Registrations
- 9
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Brufen sugar-free suspension EACH 5 ml SUSPENSION CONTAINS IBUPROFEN 100,0 mg | Suspension | 27022627/2.7/0226 | Registered | Not determined | None |
| Brufen granules EACH SACHET CONTAINS IBUPROFEN 600 mg | Granules | 27039627/3.1/0396 | Registered | Not determined | None |
| Brufen 400 MG rapid EACH CAPSULE CONTAINS IBUPROFEN 400,0 mg | 400 mg | 56092656/2.7/0926 | Registered | Not determined | None |
| Brufen 200 EACH TABLET CONTAINS IBUPROFEN 200 mg | 200mgTablets | A0727A/3.1/727Approved 2 October 2015 | Registered | S1 | PIPIL |
| Brufen 400 extra strength EACH TABLET CONTAINS IBUPROFEN 400,0 mg | 400 | H0039H/3.1/39 | Registered | Not determined | None |
| Brufen for children EACH 5 ml CONTAINS IBUPROFEN 100,0 mg | Not listed | Q0323Q/3.1/323 | Registered | Not determined | None |
| Brufen 600 EACH TABLET CONTAINS IBUPROFEN 600,0 mg | 600 | R0071R/3.1/71 | Registered | Not determined | None |
| Brufen retard EACH TABLET CONTAINS IBUPROFEN 800,0 mg | Not listed | Y0013Y/3.1/13 | Registered | Not determined | None |
| Brufen suspension ds EACH 5 ml CONTAINS IBUPROFEN 200,0 mg | Suspension | Z0173Z/3.1/173 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; 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: Antirheumatics (anti-inflammatory agents). (class 3.1)
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.
2-[4-(2-Methylpropyl)phenyl]propanoic acid
Drag to rotate. Structure from PubChem CID 3672.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.