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Antazoline, tetrahydrozoline

Sold as Oculerge, Ciballerge, Spersallerg sdu (single dose unit), Gemini, Spersallerg

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.

Background

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Registration

Applicants
2
Registrations
5
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharmacare limited û woodmeadOculergeNot stated310144Not determinedNone
Adcock ingram limited1 of 4 cancelledCiballerge, Spersallerg sdu (single dose unit), Gemini, Spersallerg0.5 mg /1 ml, 1 ml330063, 360357, H1254, H1283S2PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Oculerge

EACH 1 ml LIQIUD CONTAINS ANTAZOLINE HYDROCHLORIDE 0,5 mg TETRAHYDROZOLINE HYDROCHLORIDE 0,4 mg

Not listed31014431/15.4/0144RegisteredNot determinedNone
Ciballerge

EACH 1,0 ml SOLUTION CONTAINS ANTAZOLINE HYDROCHLORIDE 0,50 mg TETRAHYDROZOLINE HYDROCHLORIDE 0,40 mg

Not listed33006333/15.4/0063CancelledNot determinedNone
Spersallerg sdu (single dose unit)

EACH 0,3 ml DROPS CONTAINS :ANTAZOLINE HYDROCHLORIDE 0,15 mg, TETRAHYDROZOLINE HYDROCHLORIDE 0,12 mg

Not listed36035736/26/0357RegisteredNot determinedNone
Gemini

EACH 100 ml CONTAINS ANTAZOLINE HYDROCHLORIDE A 50,0 mg TETRAHYDROZOLINE HYDROCHLORIDE A 40,0 mg

1 mlSterile eye drops.H1254Approved 21 February 2023Old MedicineS2PIPIL
Spersallerg

EACH 100 ml CONTAINS ANTAZOLINE HYDROCHLORIDE A 0,05 g TETRAHYDROZOLINE HYDROCHLORIDE A 0,04 g

0.5 mg /1 ml.Sterile eye dropsH1283Approved 21 February 2022Old MedicineNot determinedPIPIL

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.

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 Antazoline hydrochloride, tetrahydrozoline hydrochloride

  • S2: Antazoline

    Consolidated Schedules 06 July 2026, line 1590

  • S2: Tetrahydrozoline

    • except when intended for nasal use.

    Consolidated Schedules 06 July 2026, line 2717

  • S1: Tetrahydrozoline

    • when intended for nasal use.

    Consolidated Schedules 06 July 2026, line 1106

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

Gemini, Adcock ingram limited is scheduled S2 in its official SAHPRA documents, read with 90% confidence.

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

Research articles

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