Codeine, paracetamol (Spectrapain, Infapain)

Listings for this ingredient that could not be applied to this product

• 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

• 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.