Paracetamol, pseudoephedrine

Sold as Sinumax ped, Sinugesic, Sinutab sinus pain non drowsy, Flusin sinus, Sudafed sinus pain, Sinumax

S2Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

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Registration

Applicants: 4
Registrations: 6
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Janssen Pharmaceutica (Pty) LtdCancelled	Sinumax ped	Not stated	300419	Not determined	None
Pharmacare limited û woodmeadCertificate held by Pharmacare limited	Sinugesic, Flusin sinus	30 mg/ 500 mg, tablets	340196, 380111	S2	PI PIL
Johnson & Johnson (Pty) Ltd û East LondonCertificate held by Johnson &Amp, Johnson (Pty) Ltd, Johnson &Amp; Johnson (Pty) Ltd	Sinutab sinus pain non drowsy, Sudafed sinus pain	30 mg, 60 mg, 500 mg, 500 mg	370138, T0196	S2	PI PIL
Johnson & Johnson (Pty) Ltd û Cape Town	Sinumax	Not stated	U0088	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Sinumax ped EACH 5 ML SYRUP CONTAINS PARACETAMOL 160 MG PSEUDOEPHEDRINE HYDROCHLORIDE 15 MG	Not listed	30041930/5.8/0419	Cancelled	Not determined	None
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	PI PIL
Sinutab sinus pain non drowsy EACH TABLET CONTAINS PARACETAMOL 500,0 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mg	30 mg. 500 mgTablet.	37013837/5.8/0138Approved 20 April 2022	Registered	S2	PI PIL
Flusin sinus tablets EACH TABLET CONTAINS PARACETAMOL 500,0 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30,0 mg	Tablets	38011138/5.8/0111	Registered	Not determined	None
Sudafed sinus pain EACH TABLET CONTAINS PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg	60 mg, 500 mgTablets.	T0196T/5.8/0196Approved 20 February 2024	Registered	S2	PI PIL
Sinumax* EACH TABLET CONTAINS PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg	Not listed	U0088U/5.8/88	Registered	Not determined	None

Regulatory status

Where S2 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Sinugesic, Pharmacare limited û woodmead is scheduled S2 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsSinugesic, Pharmacare limited û woodmead Patient information leaflet (PIL)For patients and carersSinugesic, Pharmacare limited û woodmead

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

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