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Codeine, ibuprofen, paracetamol

Sold as Mybulen, Gen-payne, Mybucod, Ibumol forte, Ibupain forte, Ibugesic forte, * gen-payne forte, Discpayne, Modupayne, Myprodol

S3Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
4
Registrations
13
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharmacare limited û woodmeadCertificate held by Pharmacare limited1 of 5 cancelledMybulen, Mybucod, Ibumol forte10 mg/200 mg/350 mg, 200 mg/ 10 mg/ 250 mg300138, 360379, 360380, A380527, A390237S2PIPIL
Adcock ingram limitedCertificate held by Adcock lngram limitedGen-payne, * gen-payne forte, Discpayne, Modupayne, Myprodolcapsules, 10 mg/200 mg/250 mg, 350 mg, 200 mg, 10 mg350046, 560960, 570731, 611506, T0244, Y0119S3PIPIL
Kiara Health (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd1Ibupain forte200 mg370060S2PIPIL
Cipla Medpro (Pty) LtdIbugesic forte10 mg, 200 mg, 250 mg370135S2PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Mybulen

EACH TABLET CONTAINS CODEINE PHOSPHATE 10 mg IBUPROFEN 200 mg PARACETAMOL 350 mg

Not listed30013830/2.8/0138RegisteredNot determinedNone
Gen-payne capsules

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg

Capsules35004635/2.8/0046RegisteredNot determinedNone
Mybucod

EACH TABLET CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 350,0 mg

10 mg/200 mg/350 mgFilm-coated tablets36037936/2.8/0379Approved 24 October 2025RegisteredS2PIPIL
Ibumol forte

EACH TABLET CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 350,0 mg

Not listed36038036/2.8/0380CancelledNot determinedNone
Ibupain forte

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg

200 mgCapsules37006037/2.8/0060Approved 29 September 2023RegisteredS2PIPIL
Ibugesic forte

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg

200 mg. 250 mg. 10 mgCapsules37013537/2.8/0135Approved 15 October 2024RegisteredS2PIPIL
* gen-payne forte

EACH TABLET CONTAINS: PARACETAMOL 350,0 mg, IBUPROFEN 200,0 mg, CODEINE PHOSPHATE 10,0 mg

Not listed56096056/2.8/0960RegisteredNot determinedNone
Discpayne

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10,0 mg, IBUPROFEN 200,0 mg, PARACETAMOL 250,0 mg

Not listed57073157/2.8/0731RegisteredNot determinedNone
Modupayne

EACH TABLET CONTAINS: PARACETAMOL 350,0 mg IBUPROFEN 200,0 mg CODEINE PHOSPHATE 10,0 mg

350 mg, 200 mg, 10 mgFilm-coated tablet61150661/2.8/1506Approved 12 May 2026RegisteredNot determinedPIPIL
Mybulen capsules

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg

200 mg/ 10 mg/ 250 mgCapsulesA380527A38/2.8/0527Approved 23 December 2022RegisteredS2PIPIL
Mybulen suspension

EACH 10,0 ml SUSPENSION CONTAINS CODEINE PHOSPHATE 10,0 mg IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg

200 mg/ 10 mg/ 250 mgSuspensionA390237A39/2.8/0237Approved 18 November 2024RegisteredS2PIPIL
Myprodol capsules

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10 mg IBUPROFEN 2OO mg PARACETAMOL 250 mg

10 mg/200 mg/250 mg.Hard capsules.T0244T/2.8/244Approved 18 October 2024RegisteredS3PIPIL
Myprodol suspension

EACH 10 ml SUSPENSION CONTAINS CODEINE PHOSPHATE 10 mg IBUPROFEN 200 mg PARACETAMOL 250 mg

10 mg/200 mg/250 mgSuspensionY0119Y/2.8/119Approved 14 March 2025RegisteredS3PIPIL

Regulatory status

Where S3 sits on the scale

Needs a doctor's prescription, dispensed by a pharmacist.

Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S6; the leaflet's S3 applies to this product.

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 Codeine phosphate, ibuprofen, paracetamol

  • S6: Codeine

    • single component codeine preparations;
    • oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3)
    • liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3)

    Consolidated Schedules 06 July 2026, lines 10128 to 10136

  • 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: Codeine

    • oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export;
    • liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export;
    • except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
    • except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
    • except single component codeine preparations. (S6)

    Consolidated Schedules 06 July 2026, lines 3350 to 3372

  • 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

  • S3: Paracetamol

    • when intended for injection.

    Consolidated Schedules 06 July 2026, line 4093

  • S2: Codeine

    • oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days, and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export;
    • liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres, when contained in products registered in terms of the Act, and not intended for export;
    • except oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit; (S3)
    • except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit; (S3)
    • except single component codeine preparations. (S6)

    Consolidated Schedules 06 July 2026, lines 1758 to 1778

  • 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

  • S2: Paracetamol

    • when contained in rectal suppositories, or
    • when contained in modified release formulations. (S0, S1, S3)

    Consolidated Schedules 06 July 2026, lines 2496 to 2500

  • 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

  • S1: Paracetamol

    • immediate release tablets or capsules each containing 500 milligrams or less of paracetamol, or in individually wrapped powders or in sachets containing 1 000 milligrams or less of paracetamol, subject to - (i) a maximum of 12,5 grams of paracetamol per primary pack, and (ii) in the case of tablets or capsules, presented in blister strip packaging or in containers with child-resistant closures; and (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
    • in liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres or in paediatric drops containing 120 milligrams or less of paracetamol per 1,2 millilitres, subject to - (i) a maximum of 100 millilitres per primary pack in the case of the liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres; (ii) a maximum of 20 millilitres per primary pack in the case of the paediatric drops; (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
    • when contained in rectal suppositories. (S2)
    • when contained in modified release formulations. (S2)
    • when intended for injection. (S3)

    Consolidated Schedules 06 July 2026, lines 958 to 997

Pharmacological class: Analgesic combinations. (class 2.8)

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Mybucod, Pharmacare limited û woodmead is scheduled S2 in its official SAHPRA documents, read with 90% confidence.

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

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