Paracetamol (Calpol, Calpol Berryblaze Paediatric, Calpol Paediatric)
Paracetamol
Haleon South Africa (Pty) Ltd
Registration
- Applicant
- Haleon South Africa (Pty) Ltd
- Certificate holder
- Glaxosmithkline Consumer Healthcare South Africa (Pty) Ltd
- Registrations
- 3
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Calpol tablets EACH TABLET COPNTAINS: PARACETAMOL 500,0 mg | 500 mgFilm-coated tablets | 44032144/2.7/0321Approved 6 November 2020 | Registered | Not determined | PIPIL |
| Calpol berryblaze paediatric suspension EACH 5,0 ml SUSPENSION CONTAINS: PARACETAMOL 120,0 mg | Suspension | 56107556/2.7/1075 | Registered | Not determined | None |
| Calpol paediatric suspension EACH 5 ml SUSPENSION CONTAINS: PARACETAMOL 120 mg | Suspension | B0767B/2.7/767 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.