Phenylephrine Hydrochloride
3-[(1R)-1-Hydroxy-2-(methylamino)ethyl]phenol
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 6041.
Registration
- Applicants
- 2
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Abbott Laboratories S.A. (Pty) LtdCertificate held by Abbott Laboratories South Africa (Pty) Ltd | Phenylephrine hydrochloride | 10 mg/mL | H0630 | S4 | PIPIL |
| Adcock ingram limitedCertificate held by Abbott Laboratories South Africa (Pty) Ltd | Phenylephrine hydrochloride | 10 mg/mL | LX0113 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Phenylephrine hydrochloride injection EACH I ml CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 10 mg | 10 mg/mLSolution for injection. | H0630Approved 5 October 2022 | Old Medicine | S4 | PIPIL |
| Phenylephrine hydrochloride injection EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/mLSolution for injection. | LX0113L/5.1/113Approved 5 October 2022 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.
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 Phenylephrine
S4: Phenylephrine
- when intended for injection
- except ophthalmic preparations containing 0,2 percent or less. (S0)
- except for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent (S1)
Consolidated Schedules 06 July 2026, lines 7545 to 7552
S1: Phenylephrine
- when intended for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent; (S1)
- except ophthalmic preparations containing 0,2 percent or less; (S0)
- except when intended for injection. (S4)
Consolidated Schedules 06 July 2026, lines 1007 to 1014
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.
Background
SAHPRA documents
Schedule Verification
Phenylephrine hydrochloride injection, Abbott Laboratories S.A. (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.