Phenylpropanolamine (Phenylephrine Hetero)
Phenylpropanolamine
Hetero Drugs South Africa (Pty) Ltd
Registration
- Applicant
- Hetero Drugs South Africa (Pty) Ltd
- Registrations
- 2
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Phenylephrine 10 mg/ml hetero EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/ml | 59045859/7.2/0458 | Registered | Not determined | None |
| Phenylephrine 50 mg/5 ML hetero EACH 5,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 50,0 mg | 50 mg/5 ml | 59045959/7.2/0459 | Registered | 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: Phenylpropanolamine
- except products registered in terms of the Act, not intended for export and oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S2)
Consolidated Schedules 06 July 2026, lines 10387 to 10394
S2: Phenylpropanolamine
- contained in products registered in terms of the Act, and not intended for export, unless listed separately in the Schedules,
- oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S6)
Consolidated Schedules 06 July 2026, lines 2516 to 2523
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.
(1R,2S)-2-Amino-1-phenylpropan-1-ol
Drag to rotate. Structure from PubChem CID 10297.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.