Bromhexine
Sold as Bronahex, Dur-elix mucolytic, Bisolvon vet, Bisolvon
2,4-Dibromo-6-[[cyclohexyl(methyl)amino]methyl]aniline
Drag to rotate. Structure from PubChem CID 2442.
Background
Registration
- Applicants
- 4
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmeadCancelled | Bronahex | solution | 290418 | S2 | None |
| Inova Pharmaceuticals (Pty) Ltd | Dur-elix mucolytic | Not stated | 320232 | S2 | None |
| Janssen Pharmaceutica (Pty) Ltd | Bisolvon vet, Bisolvon | Not stated | 83/327, 83/328 | S2 | None |
| Ingelheim Pharmaceuticals (Pty) Ltd û FerndaleCancelled | Bisolvon | 0,2 % | G0642 | S2 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bronahex solution EACH 5 ml SOLUTION CONTAINS BROMHEXINE HYDROCHLORIDE 10,0 mg | Solution | 29041829/10.1/0418 | Cancelled | S2 | None |
| Dur-elix mucolytic EACH 5,0 ml LIQUID CONTAINS BROMHEXINE HYDROCHLORIDE 4,0 mg | Not listed | 32023232/10.1/0232 | Registered | S2 | None |
| Bisolvon vet EACH ML SOLUTION CONTAINS BROMHEXINE HYDROCHLORIDE A 3 MG | Not listed | 83/327 | Old Medicine | S2 | None |
| Bisolvon EACH 1 g POWDER CONTAINS BROMHEXINE HYDROCHLORIDE A 10 mg | Not listed | 83/328 | Old Medicine | S2 | None |
| Bisolvon 0,2 % EACH 100 ml CONTAINS BROMHEXINE HYDROCHLORIDE A 200 mg | 0,2 % | G0642 | Cancelled | S2 | None |
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, matched to the Consolidated Schedules by ingredient, confidence high.
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
S2: Bromhexine
Consolidated Schedules 06 July 2026, line 1684
Pharmacological class: Antitussives and expectorants. (class 10.1)
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
SAHPRA has not published a professional information or patient information leaflet for this product.