Paracetamol, phenylpropanolamine, phenyltoloxamine (Sinutab Original, Sinutab 12-hour Cold And Flu, Sinutab Paediatric)

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

• S6: Phenylpropanolamine

  • except products registered in terms of the Act, not intended for export and oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S2)

  Consolidated Schedules 06 July 2026, lines 10387 to 10394

• S3: Paracetamol

  • when intended for injection.

  Consolidated Schedules 06 July 2026, line 4093

• 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: Phenylpropanolamine

  • contained in products registered in terms of the Act, and not intended for export, unless listed separately in the Schedules,
  • oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S6)

  Consolidated Schedules 06 July 2026, lines 2516 to 2523

• S2: Phenyltoloxamine

  Consolidated Schedules 06 July 2026, line 2525

• 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.