Paracetamol (Cetafuse Iv, Acutev)
Paracetamol
Teva Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Teva Pharmaceuticals (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
Regulatory status
Where S0 sits on the scale
Sold anywhere, no pharmacist needed.
This is the least restricted tier of medicine. You can buy it in an ordinary shop such as a supermarket or petrol station, and no pharmacist needs to be involved in the sale. It may also be advertised to the public, subject to the general advertising rules that apply to all medicines; the label must still carry the schedule mark like every other tier.
Schedule S0, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S3; the leaflet's S0 applies to this product.
Who may supply: Anyone. It may be sold in an ordinary shop, not only in a pharmacy.
Consolidated Schedules listings for Paracetamol
S3: Paracetamol
- when intended for injection.
Consolidated Schedules 06 July 2026, line 4093
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: 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: Antipyretics or antipyretic and anti-inflammatory analgesics. (class 2.7)
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
This medication's schedule (S0) 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.