Paracetamol, pseudoephedrine (Sinugesic, Flusin Sinus)
Paracetamol, pseudoephedrine
Pharmacare limited û woodmead
Registration
- Applicant
- Pharmacare limited û woodmead
- Certificate holder
- Pharmacare limited
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sinugesic EACH TABLET CONTAINS PARACETAMOL 500,0 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mg | 30 mg/ 500 mgTablets | 34019634/5.8/0196Approved 16 January 2026 | Registered | S2 | PIPIL |
| Flusin sinus tablets EACH TABLET CONTAINS PARACETAMOL 500,0 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mg | Tablets | 38011138/5.8/0111 | Registered | 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 Paracetamol, pseudoephedrine hydrochloride
S6: Pseudoephedrine
- except contained in products registered in terms of the Act, and not intended for export, being oral preparations and mixtures containing not more than 60 milligrams or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S2)
Consolidated Schedules 06 July 2026, lines 10412 to 10417
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: Pseudoephedrine
- contained in products registered in terms of the Act, and not intended for export,
- Immediate-release oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine per dose or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S6)
Consolidated Schedules 06 July 2026, lines 2600 to 2607
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: Preparations for the common cold including nasal decongestants. (class 5.8)
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
Schedule Verification
This medication's schedule (S2) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.