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zameds

Dimethindene, phenylephrine

Sold as Vibrocil-s nasal, Vibrocil-s

Combination product

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

Background

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Registration

Applicants
2
Registrations
2

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline Consumer Healthcare SA (Pty) LtdVibrocil-s nasalgelG0227Not determinedNone
Haleon South Africa (Pty) LtdVibrocil-ssolutionW0093Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Vibrocil-s nasal gel

EACH 100 g GEL CONTAINS DIMETHINDENE MALEATE 0,025 g PHENYLEPHRINE 0,25 g

GelG0227G/16.1/227RegisteredNot determinedNone
Vibrocil-s solution

EACH 100 ml SOLUTION CONTAINS: DIMETHINDENE MALEATE 25 mg, PHENYLEPHRINE 250 mg

SolutionW0093W/16.1/93RegisteredNot 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

  • S4: Phenylephrine

    • when intended for injection
    • except ophthalmic preparations containing 0,2 percent or less. (S0)
    • except for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent (S1)

    Consolidated Schedules 06 July 2026, lines 7545 to 7552

  • S2: Dimethindene

    Consolidated Schedules 06 July 2026, line 1854

  • S1: Phenylephrine

    • when intended for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent; (S1)
    • except ophthalmic preparations containing 0,2 percent or less; (S0)
    • except when intended for injection. (S4)

    Consolidated Schedules 06 July 2026, lines 1007 to 1014

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

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

Research articles

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