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Adco Labetalol

Labetalol

S3Read from the PI-PIL document and verified
Loading the molecular structure
C19H24N2O3328.40 g/mol

2-Hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 3869.

Registration

Applicants
1
Registrations
1
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Adcock Ingram Critical Care (Pty) LtdAdco labetalol5 mg/ml430661S3PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Adco labetalol 5 mg/ml

EACH 1,0 ml CONTAINS: LABETALOL HYDROCHLORIDE 5,0 mg

5 mg/mlSolution for injection43066143/7.1.3/0661Approved 20 May 2025RegisteredS3PIPIL

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.

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 Labetalol hydrochloride

  • S3: Labetalol

    Consolidated Schedules 06 July 2026, line 3862

Pharmacological class: Other hypotensives. (class 7.1.3)

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

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Adco labetalol 5 mg/ml, Adcock Ingram Critical Care (Pty) Ltd is scheduled S3 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.

Research articles

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