Phenylephrine (Phenylephrine Eye, Optimed, Naphensyl)
Phenylephrine
The Premier Pharmaceutical Co Ltd
Every registration of this product has been cancelled.
Registration
- Applicant
- The Premier Pharmaceutical Co Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Phenylephrine eye drops EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 1,0 mg | Drops | H1307 | Cancelled | Not determined | None |
| Optimed EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 12,5 mg | Not listed | H1310 | Cancelled | Not determined | None |
| Naphensyl 1 % EACH 10 ml CONTAINS :PHENYLEPHRINE HYDROCHLORIDE A 100 mg | 1 % | H1403 | Cancelled | Not determined | None |
| Naphensyl 0,25 % EACH 1 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 2,5 mg | 0,25 % | H1596 | 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
S4: Phenylephrine
- when intended for injection
- except ophthalmic preparations containing 0,2 percent or less. (S0)
- except for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent (S1)
Consolidated Schedules 06 July 2026, lines 7545 to 7552
S1: Phenylephrine
- when intended for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent; (S1)
- except ophthalmic preparations containing 0,2 percent or less; (S0)
- except when intended for injection. (S4)
Consolidated Schedules 06 July 2026, lines 1007 to 1014
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.
3-[(1R)-1-Hydroxy-2-(methylamino)ethyl]phenol
Drag to rotate. Structure from PubChem CID 6041.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.