Caffeine, codeine, doxylamine, paracetamol
Sold as Paxidal, Tensodol, Zurich-paxidal, Sedapain, Copa-dol, Doxsyn, Pharmadol, Doxy co, Resdol, Tensopyn, Codoxol, B-dol, Nomopain, Pynstop, Betapyn, Doxagesic, Sedinol, Lenapain, *Para-comb, Adco-dol, Dolerax, Syndol, Acurate
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 15
- Registrations
- 24
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limited3 of 6 cancelled | Paxidal, Pynstop, Betapyn, Adco-dol, Dolerax, Syndol | 2 mg, 5mg / 10mg / 45mg / 450mg, 10 mg | 270502, C0233, F0007, U0159, V0001, X0293 | Not determined | PIPIL |
| Cipla Medpro (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd. | Tensodol, Tensopyn | effervescent, 450 mg | 280383, 330380, T0079 | Not determined | PIPIL |
| The Premier Pharmaceutical Co LtdCancelled | Zurich-paxidal, Doxagesic | Not stated | 280500, F0039 | Not determined | None |
| Acino Pharma (Pty) LtdCertificate held by Litha Pharma (Pty) Ltd | Sedapain | 10 mg, 5 mg, 450 mg, 30 mg | 280523 | Not determined | PIPIL |
| Phyto Otc Health (Pty) Ltd | Copa-dol | Not stated | 290682 | Not determined | None |
| Medicine Developers International (Pty) Ltd | Doxsyn | Not stated | 320725 | Not determined | None |
| Dezzo Trading 392 (Pty) Ltd | Pharmadol | Not stated | 320726 | Not determined | None |
| Gulf Drug Company (Pty) Ltd | Doxy co | Not stated | 330098 | Not determined | None |
| Shanur Healthcare (Pty) Ltd | Resdol | Not stated | 330187 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Codoxol | Not stated | 340489 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | B-dol | 10 mg | 350065 | S2 | PIPIL |
| Lebasi Pharmaceuticals (Pty) Ltd | Nomopain | 450 mg, 5 mg, 30 mg, 10 mg | 360270 | S2 | PIPIL |
| Pharmacare limited û woodmead | Sedinol, Lenapain | Not stated | L0335, Q0301 | Not determined | None |
| Biotech Laboratories (Pty) Ltd | *Para-comb | Not stated | S0241 | Not determined | None |
| Teva Pharmaceuticals (Pty) Ltd | Acurate | 450 mg, 5 mg, 30 mg, 10 mg | Z0221 | S2 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Paxidal EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | 27050227/2.8/0502 | Cancelled | Not determined | None |
| Tensodol EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | 28038328/2.8/0383 | Registered | Not determined | None |
| Zurich-paxidal* EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | 28050028/2.8/0500 | Cancelled | Not determined | None |
| Sedapain EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 10 mg, 5 mg, 450 mg, 30 mgTablets | 28052328/2.8/0523Approved 19 April 2024 | Registered | Not determined | PIPIL |
| Copa-dol EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | Not listed | 29068229/2.8/0682 | Registered | Not determined | None |
| Doxsyn EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | Not listed | 32072532/2.8/0725 | Registered | Not determined | None |
| Pharmadol EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | Not listed | 32072632/2.8/0726 | Registered | Not determined | None |
| Doxy co EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | Not listed | 33009833/2.8/0098 | Registered | Not determined | None |
| Resdol EACH TABLET CONTAINS: CAFFEINE 30,0 mg, CODEINE PHOSPHATE 10,0 mg, DOXYLAMINE SUCCINATE 5,0 mg, PARACETAMOL 450,0 mg | Not listed | 33018733/2.8/0187 | Registered | Not determined | None |
| Tensopyn effervescent EACH TABLET CONTAINS CAFFEINE 50,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | Effervescent | 33038033/2.8/0380 | Registered | Not determined | None |
| Codoxol EACH TABLET CONTAINS CAFFEINE 30,0 mgCODEINE PHOSPHATE 10,0 mgDOXYLAMINE SUCCINATE 5,0 mgPARACETAMOL 450,0 mg | Not listed | 34048934/2.8/0489 | Registered | Not determined | None |
| B-dol EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | 10 mgTablets | 35006535/2.8/0065Approved 30 May 2024 | Registered | S2 | PIPIL |
| Nomopain EACH TABLET CONTAINS CAFFEINE 30,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450,0 mg | 450 mg, 5 mg, 30 mg, 10 mgTablets | 36027036/2.8/0270Approved 28 September 2023 | Registered | S2 | PIPIL |
| Pynstop EACH TABLET CONTAINS CAFFEINE 45 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 5mg / 10mg / 45mg / 450mgTablet | C0233C/2.8/233Approved 4 March 2026 | Registered | Not determined | PIPIL |
| Betapyn EACH TABLET CONTAINS CAFFEINE 50 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 10 mgTablets | F0007F/2.8/7Approved 30 November 2021 | Registered | Not determined | PIPIL |
| Doxagesic* EACH TABLET CONTAINS CAFFEINE 50 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | F0039F/2.9/39 | Cancelled | Not determined | None |
| Sedinol EACH TABLET CONTAINS CAFFEINE 30 MG CODEINE PHOSPHATE 10 MG DOXYLAMINE SUCCINATE 5 MG PARACETAMOL 450 MG | Not listed | L0335L/2.8/335 | Registered | Not determined | None |
| Lenapain EACH TABLET CONTAINS CAFFEINE ANHYDROUS 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | Q0301Q/2.9/301 | Registered | Not determined | None |
| *Para-comb EACH TABLET CONTAINS :CAFFEINE 50 mg, CODEINE PHOSPHATE 10 mg, DOXYLAMINE SUCCINATE 5,0 mg, PARACETAMOL 450 mg | Not listed | S0241S/2.8/241 | Registered | Not determined | None |
| Tensopyn EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 450 mgTablets | T0079T/2.9/79Approved 11 February 2025 | Registered | Not determined | PIPIL |
| Adco-dol EACH TABLET CONTAINS CAFFEINE 45,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450 mg | 2 mgTablet | U0159U/2.8/159Approved 10 April 2026 | Registered | Not determined | PIPIL |
| Dolerax* EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | Not listed | V0001V/2.8/1 | Cancelled | Not determined | None |
| Syndol EACH TABLET CONTAINS CAFFEINE ANHYDROUS 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 10 mgTablets | X0293X/2.8/293Approved 15 January 2026 | Cancelled | Not determined | PIPIL |
| Acurate EACH TABLET CONTAINS CAFFEINE 30 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg | 450 mg, 5 mg, 30 mg, 10 mgTablets. | Z0221Z/2.8/221Approved 31 October 2024 | Registered | S2 | PIPIL |
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 Caffeine, codeine phosphate, doxylamine succinate, paracetamol
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: Caffeine
- when intended for injection.
Consolidated Schedules 06 July 2026, line 3256
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: Doxylamine
Consolidated Schedules 06 July 2026, line 1877
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
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
Pharmacological class: Analgesic combinations. (class 2.8)
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.