Bromhexine, salbutamol
Sold as Pholtex chesty cough, Duro-tuss
4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
Drag to rotate. Structure from PubChem CID 2083.
Background
Registration
- Applicants
- 1
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pholtex chesty cough EACH 5,0 ml LIQUID CONTAINS: BROMHEXINE HYDROCHLORIDE 4,0 mg; SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,0 mg | 4 mg. 2.41 mg/5 mlLiquid | 51069851/10.1/0698Approved 26 August 2021 | Registered | Not determined | PIPIL |
| Duro-tuss linctus EACH 5,0 ml LIQUID CONTAINS BROMHEXINE HYDROCHLORIDE 4,0 mg SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,0 mg | 2.41 mg/5 mlLiquid | A390390A39/10.1/0390Approved 26 August 2021 | Registered | S2 | PIPIL |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Bromhexine hydrochloride, salbutamol sulphate equivalent to salbutamol
S4: Salbutamol
- when intended for injection.
Consolidated Schedules 06 July 2026, line 7867
S3: Ipratropium
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 3804
S3: Salbutamol
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 4238
S2: Ipratropium
- except when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 2177
S2: Salbutamol
- when contained in respirator solutions; (S3) and
- when intended for injection. (S4)
Consolidated Schedules 06 July 2026, lines 2654 to 2658
Pharmacological class: Antitussives and expectorants. (class 10.1)
Matched through the component Ipratropium.
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.