Codeine, paracetamol, promethazine
Sold as Astrapain, Vacudol, Goldgesic, Adco-salterpyn, Kid-eeze, Gsa-para-cod-prometh s, Stopayne, Tenston, Lentogesic, Stilpane, Infapain forte, Pedpain, Painagon, Ban pain, Mepromol, Megapyn, Synaleve paediatric, Pyngesic forte, Adco-kiddipayne, Dynapayne, Lesspain /stroop, Depain, Dimiprol
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 10
- Registrations
- 23
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Astral Pharma (Pty) Ltd | Astrapain | 120 mg | 270139 | Not determined | PIPIL |
| Acino Pharma (Pty) Ltd | Vacudol | syrup | 270229 | Not determined | None |
| Shanur Healthcare (Pty) Ltd | Goldgesic, Kid-eeze | syrup | 270242, 280423 | Not determined | None |
| Adcock ingram limited9 of 10 cancelled | Adco-salterpyn, Gsa-para-cod-prometh s, Stopayne, Lentogesic, Mepromol, Synaleve paediatric, Adco-kiddipayne, Lesspain /stroop, Depain, Dimiprol | syrup, syrup/stroop | 270575, 280463, B0867, F0261, X0174, X0281, X0413, Y0323, Z0161, Z0399 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Tenston | Not stated | B1126 | Not determined | None |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited3 of 4 cancelled | Stilpane, Pedpain, Ban pain, Megapyn | 10 mg/200 mg/350 mg, syrup | G0968, Q0245, X0032, X0241 | S2 | PIPIL |
| Alliance Pharma (Pty) Ltd | Infapain forte | Not stated | N0101 | Not determined | None |
| Ranbaxy (SA) (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Painagon | 5 ml | S0029 | S2 | PIPIL |
| Cipla Medpro (Pty) Ltd | Pyngesic forte | syrup | X0299 | Not determined | None |
| Aquila Healthcare (Pty) Ltd | Dynapayne | syrup | Y0238 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Astrapain syrup EACH 5 ML SYRUP CONTAINS CODEINE PHOSPHATE 5 MG PARACETAMOL 120 MG PROMETHAZINE HYDROCHLORIDE 6,5 MG | 120 mgSyrup | 27013927/2.8/0139Approved 31 December 2023 | Registered | Not determined | PIPIL |
| Vacudol syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | 27022927/2.8/0229 | Registered | Not determined | None |
| Goldgesic syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | 27024227/2.8/0242 | Registered | Not determined | None |
| Adco-salterpyn syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | 27057527/2.8/0575 | Cancelled | Not determined | None |
| Kid-eeze EACH 5 ml SYRUP CONTAINS :CODEINE PHOSPHATE 5 mg, PARACETAMOL 120 mg, PROMETHAZINE HYDROCHLORIDE 6,5 mg | Not listed | 28042328/2.8/0423 | Registered | Not determined | None |
| Gsa-para-cod-prometh s EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,50 mg | Not listed | 28046328/2.8/0463 | Cancelled | Not determined | None |
| Stopayne syrup EACH 5 ml CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | B0867B/2.8/867 | Registered | Not determined | None |
| Tenston EACH 5 ml SOLUTION CONTAINS CODEINE PHOSPHATE A 5 mg PARACETAMOL A 120 mg PROMETHAZINE HYDROCHLORIDE A 7 mg | Not listed | B1126 | Cancelled | Not determined | None |
| Lentogesic syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | F0261F/2.8/261 | Cancelled | Not determined | None |
| Stilpane syrup EACH 5 ml CONTAINS CODEINE PHOSPHATE A 5 mg PARACETAMOL A 120 mg PROMETHAZINE HYDROCHLORIDE A 6,5 mg | 10 mg/200 mg/350 mgSyrup | G0968Approved 1 July 2024 | Old Medicine | S2 | PIPIL |
| Infapain forte EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5,0 mg PARACETAMOL 120,0 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Not listed | N0101N/2.9/101 | Registered | Not determined | None |
| Pedpain EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Not listed | Q0245Q/2.9/245 | Cancelled | Not determined | None |
| Painagon syrup* EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | 5 mlSyrup | S0029S/2.8/29Approved 25 August 2023 | Registered | S2 | PIPIL |
| Ban pain syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | X0032X/2.8/32 | Cancelled | Not determined | None |
| Mepromol syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | X0174X/2.8/174 | Cancelled | Not determined | None |
| Megapyn syrup EACH 5 ml CONTAINS CODEINE PHOSPHATE 5,0 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | X0241X/2.8/241 | Cancelled | Not determined | None |
| Synaleve paediatric syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | X0281X/2.8/281 | Cancelled | Not determined | None |
| Pyngesic forte syrup EACH 5,0 ml SYRUP CONTAINS CODEINE PHOSPHATE 5,0 mg PARACETAMOL 120,0 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | X0299X/2.8/299 | Registered | Not determined | None |
| Adco-kiddipayne EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Not listed | X0413X/2.8/413 | Cancelled | Not determined | None |
| Dynapayne syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | Y0238Y/2.8/238 | Registered | Not determined | None |
| Lesspain - syrup/stroop EAVH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | -Syrup/stroop | Y0323Y/2.8/323 | Cancelled | Not determined | None |
| Depain syrup EACH 5 ml SYRUP CONTAINS CODEINE PHOSPHATE 5 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | Z0161Z/2.8/161 | Cancelled | Not determined | None |
| Dimiprol syrup EACH 5 ml CONTAINS CODEINE PHOSPHATE 5,0 mg PARACETAMOL 120 mg PROMETHAZINE HYDROCHLORIDE 6,5 mg | Syrup | Z0399Z/2.8/399 | Cancelled | Not determined | None |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S2, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S6; the leaflet's S2 applies to this product.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Codeine phosphate, paracetamol, promethazine hydrochloride
S6: Codeine
- single component codeine preparations;
- oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3)
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3)
Consolidated Schedules 06 July 2026, lines 10128 to 10136
S3: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 3350 to 3372
S3: Paracetamol
- when intended for injection.
Consolidated Schedules 06 July 2026, line 4093
S2: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days, and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit; (S3)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit; (S3)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 1758 to 1778
S2: Paracetamol
- when contained in rectal suppositories, or
- when contained in modified release formulations. (S0, S1, S3)
Consolidated Schedules 06 July 2026, lines 2496 to 2500
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
S1: Paracetamol
- immediate release tablets or capsules each containing 500 milligrams or less of paracetamol, or in individually wrapped powders or in sachets containing 1 000 milligrams or less of paracetamol, subject to - (i) a maximum of 12,5 grams of paracetamol per primary pack, and (ii) in the case of tablets or capsules, presented in blister strip packaging or in containers with child-resistant closures; and (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
- in liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres or in paediatric drops containing 120 milligrams or less of paracetamol per 1,2 millilitres, subject to - (i) a maximum of 100 millilitres per primary pack in the case of the liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres; (ii) a maximum of 20 millilitres per primary pack in the case of the paediatric drops; (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
- when contained in rectal suppositories. (S2)
- when contained in modified release formulations. (S2)
- when intended for injection. (S3)
Consolidated Schedules 06 July 2026, lines 958 to 997
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.