Pseudoephedrine, triprolidine
Sold as Flusin sinus, Betafed, Actifed cold, Flutex decongestant, Endcol decongestant, Tixylix flu, Decofed
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 8
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead3 of 4 cancelled | Flusin sinus, Flutex decongestant, Endcol decongestant, Tixylix flu | syrup, tablets | 300048, T0245, T0246, Y0074 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Betafed | 5 ml | 310249 | S2 | PIPIL |
| Haleon South Africa (Pty) Ltd | Actifed cold | syrup | C0973 | Not determined | None |
| Acino Pharma (Pty) Ltd | Decofed | tablets, syrup | Y0136, Y0137 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Flusin sinus syrup EACH 5 ml SOLUTION CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1,25 mg | Syrup | 30004830/5.8/0048 | Registered | Not determined | None |
| Betafed syrup EACH 5,0 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mgTRIPROLIDINE HYDROCHLORIDE 1,25 mg | 5 mlSyrup | 31024931/5.8/0249Approved 24 March 2024 | Registered | S2 | PIPIL |
| Actifed cold syrup EACH 5 ml CONTAINS: PSEUDOEPHEDRINE HYDROCHLORIDE A 30 mg, TRIPROLIDINE HYDROCHLORIDE A 1,375 mg | Syrup | C0973 | Old Medicine | Not determined | None |
| Flutex decongestant EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG TRIPROLIDINE HYDROCHLORIDE 1,25 MG | Not listed | T0245T/5.8/245 | Cancelled | Not determined | None |
| Endcol decongestant syrup EACH 5 ML CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG TRIPROLIDINE HYDROCHLORIDE 1,25 MG | Syrup | T0246T/5.8/246 | Cancelled | Not determined | None |
| Tixylix flu tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1,25 mg | Tablets | Y0074Y/5.8/74 | Cancelled | Not determined | None |
| Decofed tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mgTRIPROLIDINE HYDROCHLORIDE 1,25 mg | Tablets | Y0136Y/5.8/136 | Registered | Not determined | None |
| Decofed syrup EACH 5 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mgTRIPROLIDINE HYDROCHLORIDE 1,25 mg | Syrup | Y0137Y/5.8/137 | Registered | Not determined | 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, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S6; 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 Pseudoephedrine hydrochloride, triprolidine hydrochloride
S6: Pseudoephedrine
- except contained in products registered in terms of the Act, and not intended for export, being oral preparations and mixtures containing not more than 60 milligrams or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S2)
Consolidated Schedules 06 July 2026, lines 10412 to 10417
S2: Pseudoephedrine
- contained in products registered in terms of the Act, and not intended for export,
- Immediate-release oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine per dose or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S6)
Consolidated Schedules 06 July 2026, lines 2600 to 2607
S2: Triprolidine
Consolidated Schedules 06 July 2026, line 2745
Pharmacological class: Preparations for the common cold including nasal decongestants. (class 5.8)
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
Betafed syrup, Ranbaxy Pharmaceutical (Pty) Ltd is scheduled S2 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.