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Promethazine

Sold as Promethazine hcl-fresenius, Promethazine elixer, Promahist elixer, Lenazine, Phenergan, Daralix, Prohist, Delmaak-promethazine, Brunazine, Triomethazine, * promezia

Loading the molecular structure
C17H20N2S284.40 g/mol

N,N-Dimethyl-1-phenothiazin-10-ylpropan-2-amine

Drag to rotate. Structure from PubChem CID 4927.

Background

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Registration

Applicants
9
Registrations
15

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Fresenius Medical Care South Africa (Pty) LtdPromethazine hcl-fresenius25 mg, 50 mg/2 mlB1450, B1637Not determinedNone
The Premier Pharmaceutical Co LtdCancelledPromethazine elixer, Promahist elixerNot statedC0689, C0794Not determinedNone
Pharmacare limited û woodmeadLenazine, Daralix5 mg/5 ml, syrupC0829, C0883Not determinedNone
Sanofi-aventis South Africa (Pty) LtdCertificate held by Sanofi-aventis South Africa (Pty) Ltd.CancelledPhenergan10, 25 mg / mlC0855, C0857Not determinedPIPIL
Pharma-q Holdings (Pty) LtdCertificate held by Sanofi-aventis South Africa (Pty) Ltd.Phenergan25C0858Not determinedPIPIL
Ranbaxy (SA) (Pty) LtdProhistsyrupG0022Not determinedNone
Delmaak Laboratories (Pty) LtdCancelledDelmaak-promethazineelixirK0147Not determinedNone
Unimed Healthcare (Pty) LtdBrunazine, * promezia10, 25M0153, R0154, R0155Not determinedNone
Resmed healthcareTriomethazineelixirQ0006Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Promethazine hcl-fresenius 25 MG

EACH 1,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 25,0 mg

25 mgB1450Old MedicineNot determinedNone
Promethazine hcl-fresenius 50 mg/2 ML

EACH 2,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 50,0 mg

50 mg/2 mlB1637Old MedicineNot determinedNone
Promethazine elixer

5 ML PROMETHAZINE HYDROCHLORIDE A 5 MG

Not listedC0689CancelledNot determinedNone
Promahist elixer

5 ML PROMETHAZINE HYDROCHLORIDE A 5 MG

Not listedC0794CancelledNot determinedNone
Lenazine elixir 5 mg/5 ML

EACH 5,0 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 5,0 mg

5 mg/5 mlElixirC0829Old MedicineNot determinedNone
Phenergan 10

TABLET PROMETHAZINE HYDROCHLORIDE A 10 MG

10Film-coated tablets.C0855Approved 6 November 2023CancelledNot determinedPIPIL
Phenergan 25 MG / ML

EACH 1,0 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 25,0 mg

25 mg / mlC0857CancelledNot determinedNone
Phenergan 25

TABLET PROMETHAZINE HYDROCHLORIDE A 25 MG

25Film-coated tablets.C0858Approved 6 November 2023Old MedicineNot determinedPIPIL
Daralix syrup

EACH 5 ml CONTAINS PROMETHAZINE HYDROCHLORIDE A 5 mg

SyrupC0883Old MedicineNot determinedNone
Prohist syrup*

EACH 5 ml SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5 mg

SyrupG0022G/5.7/22RegisteredNot determinedNone
Delmaak-promethazine elixir

EACH 5 ML SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg

ElixirK0147K/5.7.1/147CancelledNot determinedNone
Brunazine

EACH 1,0 ml SYRUP CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg

Not listedM0153M/5.7.1/153RegisteredNot determinedNone
Triomethazine elixir

EACH 5,0 ml ELIXIR CONTAINS PROMETHAZINE HYDROCHLORIDE 5,0 mg

ElixirQ0006Q/5.7.1/0006RegisteredNot determinedNone
* promezia 10

EACH TABLET CONTAINS: PROMETHAZINE HYDROCHLORIDE 10,0 mg

10R0154R/5.7.1/154RegisteredNot determinedNone
* promezia 25

EACH TABLET CONTAINS: PROMETHAZINE HYDROCHLORIDE 25,0 mg

25R0155R/5.7.1/155RegisteredNot determinedNone

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

Research articles

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