Ibuprofen, paracetamol
Sold as Mypaid, Lotem, Mypaid forte, Ibumol, Panado plus, Ibupain, Ibugesic plus, Nurofen co, Parafengen iv, *Empaped plus, Ibumol extra, Nocomypro, Ibucetapro, Ibumol banana, Ibumol grape
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 6
- Registrations
- 16
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limitedCertificate held by Adcock | Mypaid, Lotem, Mypaid forte, Panado plus, Nocomypro, Ibucetapro | 200mg / 250mg, 200 mg /250 mg, 200 mg and 250 mg, 400 mg/ 325 mg, tablets, suspension | 270289, 300391, 310531, 350070, 570407, 600127, 600711 | S3S2 to S3 by pack | PIPIL |
| Pharmacare limited û woodmead | Ibumol, Ibumol extra, Ibumol banana, Ibumol grape | Not stated | 340089, 560114, A390228, A390229 | Not determined | None |
| Sandoz South Africa (Pty) Ltd | Ibupain | Not stated | 370133 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Ibugesic plus | 200 mg/ 250 mg | 370134 | S2 | PIPIL |
| Reckitt Benckinser Pharmaceuticals (Pty) Ltd | Nurofen co | Not stated | 460607 | Not determined | None |
| Acino Pharma (Pty) LtdCertificate held by Litha Pharma (Pty) Ltd | Parafengen iv, *Empaped plus | 5 ml, 1000 mg, 300 mg | 54/2.8/0012, 540053 | S3S2 to S3 by pack | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mypaid EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | 200mg / 250mgCapsules | 27028927/2.8/0289Approved 29 August 2025 | Registered | S2 | PIPIL |
| Lotem suspension EACH 10 ml SUSPENSION CONTAINS : IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | 200 mg /250 mgSuspension | 30039130/2.8/0391Approved 29 August 2025 | Registered | S2 | PIPIL |
| Mypaid forte EACH TABLET CONTAINS IBUPROFEN 400,0 mg PARACETAMOL 325,0 mg | Not listed | 31053131/2.8/0531 | Registered | Not determined | None |
| Ibumol EACH TABLET CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 350,0 mg | Not listed | 34008934/2.8/0089 | Registered | Not determined | None |
| Panado plus EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | 200 mg and 250 mgCapsules | 35007035/2.8/0070Approved 24 May 2023 | Registered | S2 | PIPIL |
| Ibupain EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | Not listed | 37013337/2.8/0133 | Registered | Not determined | None |
| Ibugesic plus EACH CAPSULE CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | 200 mg/ 250 mgCapsule | 37013437/2.8/0134Approved 22 March 2023 | Registered | S2 | PIPIL |
| Nurofen co Each tablet contains IBUPROFEN 200,0 mg and PARACETAMOL 500,0 mg | Not listed | 46060746/2.8/0607 | Registered | Not determined | None |
| Parafengen iv EACH 100,0 ml VIAL CONTAINS PARACETAMOL 1 000,0 mg IBUPROFEN SODIUM DIHYDRATE 300,0 mg | 1000 mg, 300 mgSolution for infusion | 54/2.8/0012Approved 15 August 2023 | Registrered | S3 | PIPIL |
| *Empaped plus suspension EACH 5,0 mg SUSPENSION CONTAINS PARACETAMOL 160,0 mg IBUPROFEN 48,0 mg | 5 mlSuspension | 54005354/2.8/0053Approved 21 November 2025 | Registered | S2 | PIPIL |
| Ibumol extra EACH TABLET CONTAINS IBUPROFEN 400,0 mg PARACETAMOL 325,0 mg | Not listed | 56011456/2.8/0114 | Registered | Not determined | None |
| Nocomypro EACH TABLET CONTAINS IBUPROFEN 400,0 mgPARACETAMOL 325,0 mg | 400 mg/ 325 mgTablet | 57040757/2.8/0407Approved 3 August 2022 | Registered | S3 | PIPIL |
| Ibucetapro tablets EACH TABLET CONTAINS IBUPROFEN 400,0 mg PARACETAMOL 325,0 mg | Tablets | 60012760/2.8/0127 | Registered | Not determined | None |
| Mypaid suspension EACH 10,0 ml SUSPENSION CONTAINS: IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | Suspension | 60071160/2.8/0711 | Registered | Not determined | None |
| Ibumol banana EACH 10,0 ml SUSPENSION CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | Not listed | A390228A39/2.8/0228 | Registered | Not determined | None |
| Ibumol grape EACH 10,0 ml SUSPENSION CONTAINS IBUPROFEN 200,0 mg PARACETAMOL 250,0 mg | Not listed | A390229A39/2.8/0229 | Registered | Not determined | None |
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 S4; 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 Paracetamol, ibuprofen sodium dihydrate
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
S3: Paracetamol
- when intended for injection.
Consolidated Schedules 06 July 2026, line 4093
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)
14 of 67 approved products with this ingredient carry S5 on their leaflet.
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 Verification
Mypaid, Adcock ingram limited 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.