Cetirizine (Zelary, Austell Cetirizine, Cetirizine Austell)
Cetirizine
Austell Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Austell Pharmaceuticals (Pty) Ltd
- Certificate holder
- Austell Pharmaceuticals (Pty) Ltd,
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zelary 10 EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgFilm-coated tablets | 37042837/5.7.1/0428Approved 18 October 2024 | Registered | S1 | PIPIL |
| Austell cetirizine 5 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg | 37057937/5.7.1/0579 | Registered | Not determined | None |
| Cetirizine 5 MG austell EACH TABLET CONTAINS: CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg | 37057937/5.7.1/0579 | Registered | Not determined | None |
| Austell cetirizine 10 MG EACH TABLET CONTAINS :CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mg | 37058037/5.7.1/0580 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Cetirizine dihydrochloride
S1: Cetirizine
Consolidated Schedules 06 July 2026, line 318
Pharmacological class: Antihistaminics. (class 5.7.1)
5 of 11 approved products with this ingredient carry S2 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.
2-[2-[4-[(4-Chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid
Drag to rotate. Structure from PubChem CID 2678.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) 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.