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Ibuprofen (Pedea)

Ibuprofen

Equity Pharmaceutical (Pty) Ltd

S4Read from the PI-PIL document and verified

Registration

Applicant
Equity Pharmaceutical (Pty) Ltd
Certificate holder
Equity Pharmaceuticals (Pty) Ltd
Registrations
1
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Pedea

EACH 2,0 ml AMPOULE CONTAINS IBUPROFEN 10,0 mg

5 mg, 10 mgSolution for injectionA400174A40/3.1/0174Approved 4 April 2025RegisteredS4PIPIL

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing 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); manufacturers and wholesalers may supply people who may lawfully possess it; 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.

C13H18O2206.28 g/mol

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

Drag to rotate. Structure from PubChem CID 3672.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.

Professional information (PI)For healthcare professionalsPatient 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.

Background

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