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Dextromethorphan, paracetamol, pseudoephedrine, vitamin c (Demazin Flu)

Dextromethorphan, paracetamol, pseudoephedrine, vitamin c

Inova Pharmaceuticals (Pty) Ltd

Registration

Applicant
Inova Pharmaceuticals (Pty) Ltd
Registrations
1

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Demazin flu

EACH TABLET CONTAINS DEXTROMETHORPHAN HYDROBROMIDE 20 mg PARACETAMOL 300 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg VITAMIN C 125 mg

Not listedY0308Y/10.2.2/308RegisteredNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

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

  • 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

  • S3: Vitamin c

    • in preparations thereof for injection; (S0)
    • except in oral preparations or mixtures containing more than 1000 mg of Vitamin C per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1)

    Consolidated Schedules 06 July 2026, lines 4435 to 4440

  • S2: Dextromethorphan

    Consolidated Schedules 06 July 2026, line 1801

  • 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

  • S1: Vitamin c

    • in oral preparations or mixtures containing more than 1000 mg of Vitamin C per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)
    • except in preparations thereof for injection. (S3)

    Consolidated Schedules 06 July 2026, lines 1184 to 1189

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

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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