Promethazine
Sold as Promethazine hcl-fresenius, Promethazine elixer, Promahist elixer, Lenazine, Phenergan, Daralix, Prohist, Delmaak-promethazine, Brunazine, Triomethazine, * promezia
N,N-Dimethyl-1-phenothiazin-10-ylpropan-2-amine
Drag to rotate. Structure from PubChem CID 4927.
Background
Registration
- Applicants
- 9
- Registrations
- 15
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fresenius Medical Care South Africa (Pty) Ltd | Promethazine hcl-fresenius | 25 mg, 50 mg/2 ml | B1450, B1637 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Promethazine elixer, Promahist elixer | Not stated | C0689, C0794 | Not determined | None |
| Pharmacare limited û woodmead | Lenazine, Daralix | 5 mg/5 ml, syrup | C0829, C0883 | Not determined | None |
| Sanofi-aventis South Africa (Pty) LtdCertificate held by Sanofi-aventis South Africa (Pty) Ltd.Cancelled | Phenergan | 10, 25 mg / ml | C0855, C0857 | Not determined | PIPIL |
| Pharma-q Holdings (Pty) LtdCertificate held by Sanofi-aventis South Africa (Pty) Ltd. | Phenergan | 25 | C0858 | Not determined | PIPIL |
| Ranbaxy (SA) (Pty) Ltd | Prohist | syrup | G0022 | Not determined | None |
| Delmaak Laboratories (Pty) LtdCancelled | Delmaak-promethazine | elixir | K0147 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Brunazine, * promezia | 10, 25 | M0153, R0154, R0155 | Not determined | None |
| Resmed healthcare | Triomethazine | elixir | Q0006 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Promethazine hcl-fresenius 25 MG EACH 1,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 25,0 mg | 25 mg | B1450 | Old Medicine | Not determined | None |
| Promethazine hcl-fresenius 50 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 50,0 mg | 50 mg/2 ml | B1637 | Old Medicine | Not determined | None |
| Promethazine elixer 5 ML PROMETHAZINE HYDROCHLORIDE A 5 MG | Not listed | C0689 | Cancelled | Not determined | None |
| Promahist elixer 5 ML PROMETHAZINE HYDROCHLORIDE A 5 MG | Not listed | C0794 | Cancelled | Not determined | None |
| Lenazine elixir 5 mg/5 ML EACH 5,0 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 5,0 mg | 5 mg/5 mlElixir | C0829 | Old Medicine | Not determined | None |
| Phenergan 10 TABLET PROMETHAZINE HYDROCHLORIDE A 10 MG | 10Film-coated tablets. | C0855Approved 6 November 2023 | Cancelled | Not determined | PIPIL |
| Phenergan 25 MG / ML EACH 1,0 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 25,0 mg | 25 mg / ml | C0857 | Cancelled | Not determined | None |
| Phenergan 25 TABLET PROMETHAZINE HYDROCHLORIDE A 25 MG | 25Film-coated tablets. | C0858Approved 6 November 2023 | Old Medicine | Not determined | PIPIL |
| Daralix syrup EACH 5 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 5 mg | Syrup | C0883 | Old Medicine | Not determined | None |
| Prohist syrup* EACH 5 ml SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5 mg | Syrup | G0022G/5.7/22 | Registered | Not determined | None |
| Delmaak-promethazine elixir EACH 5 ML SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg | Elixir | K0147K/5.7.1/147 | Cancelled | Not determined | None |
| Brunazine EACH 1,0 ml SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg | Not listed | M0153M/5.7.1/153 | Registered | Not determined | None |
| Triomethazine elixir EACH 5,0 ml ELIXIR CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg | Elixir | Q0006Q/5.7.1/0006 | Registered | Not determined | None |
| * promezia 10 EACH TABLET CONTAINS: PROMETHAZINE HYDROCHLORIDE 10,0 mg | 10 | R0154R/5.7.1/154 | Registered | Not determined | None |
| * promezia 25 EACH TABLET CONTAINS: PROMETHAZINE HYDROCHLORIDE 25,0 mg | 25 | R0155R/5.7.1/155 | 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
S2: Promethazine
- when intended for use as an antihistamine, and
- when intended for application to the skin, and
- when intended specifically for the treatment of travel sickness. (S5)
Consolidated Schedules 06 July 2026, lines 2586 to 2592
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.