Pseudoephedrine
Sold as Adco-sufedrin, Sinu-med, Adco-symptofed, Symptofed, Monofed, Drinasal s, Dykafed, Drinasal t, Dietene, Sudafed sinus, Isofedrin, Sinu-med ped
(1S,2S)-2-(Methylamino)-1-phenylpropan-1-ol
Drag to rotate. Structure from PubChem CID 7028.
Background
Registration
- Applicants
- 6
- Registrations
- 14
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limitedCancelled | Adco-sufedrin, Adco-symptofed, Symptofed, Dykafed, Dietene | tablets, syrup | 270188, 270258, 270479, 270480, 290354, 360400 | Not determined | None |
| Pharmacare limited û woodmeadCancelled | Sinu-med, Monofed, Sinu-med ped | tablets, syrup | 270470, 280497, 280510, X0170 | Not determined | None |
| Viatris South Africa (Pty) LtdCancelled | Drinasal s | Not stated | 280682 | Not determined | None |
| Acino Pharma (Pty) Ltd | Drinasal t | Not stated | 300015 | Not determined | None |
| Johnson & Johnson (Pty) Ltd û East LondonCancelled | Sudafed sinus | Not stated | F0082 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Isofedrin | Not stated | V0244 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adco-sufedrin tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Tablets | 27018827/5.8/0188 | Cancelled | Not determined | None |
| Adco-sufedrin syrup EACH 5 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg | Syrup | 27025827/5.8/0258 | Cancelled | Not determined | None |
| Sinu-med tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Tablets | 27047027/5.8/0470 | Cancelled | Not determined | None |
| Adco-symptofed EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Not listed | 27047927/5.8/0479 | Cancelled | Not determined | None |
| Symptofed syrup EACH 5 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg | Syrup | 27048027/5.8/0480 | Cancelled | Not determined | None |
| Monofed syrup EACH 5 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg | Syrup | 28049728/5.8/0497 | Cancelled | Not determined | None |
| Monofed tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Tablets | 28051028/5.8/0510 | Cancelled | Not determined | None |
| Drinasal s EACH 5 ml SOLUTION CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg | Not listed | 28068228/5.8/0682 | Cancelled | Not determined | None |
| Dykafed tablets EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Tablets | 29035429/5.8/0354 | Cancelled | Not determined | None |
| Drinasal t EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 ,0 mg | Not listed | 30001530/5.8/0015 | Registered | Not determined | None |
| Dietene syrup EACH 5,0 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 20,0 mg | Syrup | 36040036/11.3/0400 | Cancelled | Not determined | None |
| Sudafed sinus EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Not listed | F0082F/5.8/82 | Cancelled | Not determined | None |
| Isofedrin* EACH TABLET CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg | Not listed | V0244V/5.8/244 | Cancelled | Not determined | None |
| Sinu-med ped EACH 5 ml SYRUP CONTAINS PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg | Not listed | X0170X/5.8/170 | Cancelled | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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.