Acetylcysteine
Sold as Solmucol, Acc, Aloribex, Amuco, Amuco otc, Pholtex mucus, Paradote, Muco-go, Mucatak, Mucofizz, Acc on the go, Tussmuco, Gencetyl, Ukastyn, Rocylteine, Mucoloc, Acetylcysteine austell, Acetylcysteine camox, Corenza muco, Acetylcysteine adco, Flemkleer, Acetylcysteine clicks, Acetylcysteine sandoz, Acetylcysteine hexal, Acc hot, Parvolex, Mucolit
(2R)-2-Acetamido-3-sulfanylpropanoic acid
Drag to rotate. Structure from PubChem CID 12035.
Background
Registration
- Applicants
- 11
- Registrations
- 37
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmeadCertificate held by Pharmacare Ltd, Aspen pharmacare1 of 7 cancelled | Solmucol, Tussmuco, Parvolex, Mucolit | 100, 200, 200mg / 10ml, 400, 600 mg | 280128, 280129, 280451, 540854, 590104, NX0156, W0247 | S2S1 to S2 by pack | PIPIL |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd, Sandoz SA (Pty) Ltd1 | Acc, Acc on the go, Acetylcysteine clicks, Acetylcysteine sandoz, Acetylcysteine hexal, Acc hot | 200 mg, 600 mg | 290753, 450229, 510816, 580222, 590060, 590061.060, 590406 | Not determined | PIPIL |
| Ipharma (Pty) Ltd | Aloribex | 300 | 340178 | S3 | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Amuco, Amuco otc, Acetylcysteine austell, Acetylcysteine camox | 200, 600 mg | 430510, 430511, 570586, 570587.586, 570588.586 | Not determined | None |
| Inova Pharmaceuticals (Pty) Ltd | Pholtex mucus | 200 mg | 430512 | S1 | PIPIL |
| Equity Pharmaceutical (Pty) LtdCertificate held by Equity Pharmaceuticals (Pty) Ltd | Paradote | 200 mg | 440329 | Not determined | PIPIL |
| Cipla Medpro (Pty) Ltd | Muco-go, Mucatak | 200 | 440925, 440927 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Mucofizz | 200 mg | 460384 | S1 | PIPIL |
| Aurogen South Africa (Pty) Ltd2 of 6 cancelled | Gencetyl, Ukastyn, Rocylteine | 200 mg, 600 mg | 560139, 560140, 560141.139, 560142.140, 560143.139, 560144.140 | Not determined | None |
| Adcock ingram limited | Mucoloc, Corenza muco, Acetylcysteine adco | 200, 600 | 570362, 570863, 570864, 570865.863, 570866.864 | S1 | PIPIL |
| Dezzo Trading 392 (Pty) Ltd | Flemkleer | 200 | 580186 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Solmucol 200 EACH SACHET CONTAINS ACETYLCYSTEINE 200 mg | 200 | 28012828/10.2.2/0128 | Registered | Not determined | None |
| Solmucol 400 EACH SACHET CONTAINS ACETYLCYSTEINE 400,0 mg | 400 | 28012928/10.2.2/0129 | Registered | Not determined | None |
| Solmucol EACH LOZENGE CONTAINS ACETYLCYSTEINE 100 mg | Not listed | 28045128/10.2.2/0451 | Registered | Not determined | None |
| Acc 200 EACH TABLET CONTAINS ACETYLCYSTEINE 200 mg | 200 mgEffervescent tablets | 29075329/10.2.2/0753Approved 19 April 2013 | Registered | Not determined | PIL |
| Aloribex 300 EACH 3,0 g SACHET CONTAINS ACETYLCYSTEINE 200,0 mg | 300Tablets. | 34017834/3.3/0178Approved 19 April 2023 | Registered | S3 | PIPIL |
| Amuco 200 effervescent tablets EACH EFFERVESCENT TABLET CONTAINS :ACETYLCYSTEINE 200,0 mg | 200Effervescent tablets | 43051043/10.2.2/0510 | Registered | Not determined | None |
| Amuco 200 otc EACH EFFERVESCENT TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 | 43051143/10.2.2/0511 | Registered | Not determined | None |
| Pholtex mucus 200 EACH EFFERVESCENT TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mgEffervescent tablets | 43051243/10.2.2/0512Approved 4 October 2022 | Registered | S1 | PIPIL |
| Paradote EACH 1,0 ml SOLUTION CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mgConcentrate solution for dilution for iv infusion | 44032944/32.16/0329Approved 23 January 2015 | Registered | Not determined | PIPIL |
| Muco-go 200 effervescent tablets EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200Effervescent tablets | 44092544/10.1/0925 | Registered | Not determined | None |
| Mucatak 200 effervescent tablets EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200Effervescent tablets | 44092744/10.1/0927 | Registered | Not determined | None |
| Acc 600 | 600 mgEffervescent tablets | 45022945/10.3/0229Approved 28 March 2025 | Registered | Not determined | PIPIL |
| Mucofizz 200 | 200 mgWhite to off white round, flat tablets. | 46038446/10.3/0384Approved 14 January 2025 | Registered | S1 | PIPIL |
| Acc on the go Each Sachet contains: Acetylcystene 600,0 mg | Not listed | 51081651/10.3/0816 | Registered | Not determined | None |
| Tussmuco EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | Not listed | 54085454/10.3/0854 | Registered | Not determined | None |
| Gencetyl 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 56013956/10.3/0139 | Registered | Not determined | None |
| Gencetyl 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 56014056/10.3/0140 | Registered | Not determined | None |
| Ukastyn 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 560141.13956/10.3/0141.139 | Cancelled | Not determined | None |
| Ukastyn 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 560142.14056/10.3/0142.140 | Cancelled | Not determined | None |
| Rocylteine 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 560143.13956/10.3/0143.139 | Registered | Not determined | None |
| Rocylteine 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 560144.14056/10.3/0144.140 | Registered | Not determined | None |
| Mucoloc EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | Not listed | 57036257/10.3/0362 | Registered | Not determined | None |
| Amuco 600 MG granules EACH SACHET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600 mgGranules | 57058657/10.3/0586 | Registered | Not determined | None |
| Acetylcysteine 600 MG austell granules EACH SACHET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600 mgGranules | 570587.58657/10.3/0587.586 | Registered | Not determined | None |
| Acetylcysteine 600 MG camox granules EACH SACHET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600 mgGranules | 570588.58657/10.3/0588.586 | Registered | Not determined | None |
| Corenza muco 200 EACH TABLET CONTAINS: ACETYLCYSTEINE 200,0 mg | 200Effervescent tablet. | 57086357/10.3/0863Approved 18 September 2025 | Registered | S1 | PIPIL |
| Corenza muco 600 EACH TABLET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600Effervescent tablet. | 57086457/10.3/0864Approved 18 September 2025 | Registered | S1 | PIPIL |
| Acetylcysteine 200 adco EACH TABLET CONTAINS: ACETYLCYSTEINE 200,0 mg | 200Effervescent tablet. | 570865.86357/10.3/0865.863Approved 18 September 2025 | Registered | S1 | PIPIL |
| Acetylcysteine 600 adco EACH TABLET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600Effervescent tablet. | 570866.86457/10.3/0866.864Approved 18 September 2025 | Registered | S1 | PIPIL |
| Flemkleer 200 EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 | 58018658/10.2.2/0186 | Registered | Not determined | None |
| Acetylcysteine 200 clicks EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 | 58022258/10.3/0222 | Registered | Not determined | None |
| Acetylcysteine 600 sandoz EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 | 59006059/10.3/0060 | Registered | Not determined | None |
| Acetylcysteine 600 hexal EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 | 590061.06059/10.3/0061.060 | Registered | Not determined | None |
| Tussmuco 600 EACH TABLET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600 mgEffervescent tablets | 59010459/10.3/0104Approved 25 November 2025 | Registered | S1 | PIPIL |
| Acc 600 hot EACH SACHET CONTAINS: ACETYLCYSTEINE 600,0 mg | 600 | 59040659/10.3/0406 | Registered | Not determined | None |
| Parvolex EACH 5,0 ml CONTAINS ACETYLCYSTEINE 200,0 mg | 200mg / 10mlInjection | NX0156NX/34/156Approved 19 July 1984 | Registered | S2 | PI |
| Mucolit 100 EACH SACHET CONTAINS ACETYLCYSTEINE 100 MG | 100 | W0247W/10.2.2/247 | Cancelled | Not determined | None |
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 Acetylcysteine
S3: Acetylcysteine
- when intended for injection or for the management of paracetamol overdosage;
- except when used as a mucolytic in acute respiratory conditions for a maximum treatment period of 14 days. (S1)
Consolidated Schedules 06 July 2026, lines 3109 to 3114
S1: Acetylcysteine
- when used as a mucolytic in acute respiratory conditions for a maximum treatment period of 14 days;
- except when intended for injection or for the management of paracetamol overdosage. (S3)
Consolidated Schedules 06 July 2026, lines 102 to 106
Pharmacological class: Anti-gout preparations. (class 3.3)
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.
SAHPRA documents
Schedule Verification
Aloribex 300, Ipharma (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.