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Orphenadrine, paracetamol

Sold as Besemax, Uniflex, Betaflex nc, Norflex co

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
4

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Adcock ingram limitedCertificate held by Adcock ingram1 of 3 cancelledBesemax, Uniflex, Betaflex nc450mg, 450 mg300099, 320605, 320606Not determinedPIPIL
Inova Pharmaceuticals (Pty) LtdNorflex co35 mg and 450 mgB1098Not determinedPIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Besemax

EACH TABLET CONTAINS ORPHENADRINE CITRATE 35 MG PARACETAMOL 450 MG

450mgTablet30009930/2.8/0099Approved 31 January 2022RegisteredNot determinedPIPIL
Uniflex

EACH TABLET CONTAINS ORPHENADRINE CITRATE 35,0 mg PARACETAMOL 450,0 mg

450 mg.Tablets32060532/2.8/0605Approved 16 February 2024RegisteredNot determinedPIPIL
Betaflex nc

EACH TABLET CONTAINS ORPHENADRINE CITRATE 35,0 mg PARACETAMOL 450,0 mg

450 mg.Tablets32060632/2.8/0606Approved 31 January 2022CancelledNot determinedPIPIL
Norflex co

EACH TABLET CONTAINS ORPHENADRINE CITRATE A 35,0 mg PARACETAMOL A 450,0 mg

35 mg and 450 mg.TabletsB1098Approved 24 June 2021Old MedicineNot determinedPIPIL

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: Orphenadrine

    • except when contained in preparations intended for use as a muscle relaxant.

    Consolidated Schedules 06 July 2026, line 7407

  • S3: Paracetamol

    • when intended for injection.

    Consolidated Schedules 06 July 2026, line 4093

  • S2: Orphenadrine

    • when contained in preparations intended for use as a muscle relaxant.

    Consolidated Schedules 06 July 2026, line 2468

  • 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

  • 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

14 of 67 approved products with this ingredient carry S5 on their leaflet.

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

Professional information (PI)For healthcare professionalsBesemax, Adcock ingram limitedPatient information leaflet (PIL)For patients and carersBesemax, Adcock ingram limited

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

Research articles

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