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Phenylephrine

Sold as Minims phenylephrine hydrochloride, Sudafed pe sinus decongestant, Phenylephrine cipla, Hypopress, Phenpressor, Rusaine, Phenylephrine ps equity, Phenylephrine RBC, Phenylcord, Paripres, Phenylephrine hetero, Phenylephrine fresenius, Phenylephrine covan, Phenylephrine hydrochloride, Ei-deel, Phenylephrine eye, Optimed, Naphensyl, Sine off sinus, Preferin liquifilm sterile eye, Phenylephrine hydrochloride nose, Eye-gene nf eye, Fenox nasal

S4Read from the PI-PIL document and verified
Loading the molecular structure
C9H13NO2167.20 g/mol

3-[(1R)-1-Hydroxy-2-(methylamino)ethyl]phenol

Drag to rotate. Structure from PubChem CID 6041.

Background

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Registration

Applicants
19
Registrations
28
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Soflens (Pty) Ltd1 of 2 cancelledMinims phenylephrine hydrochloride2,5 %, 10 %310458, D0022Not determinedNone
Johnson & Johnson (Pty) Ltd û East LondonCancelledSudafed pe sinus decongestantNot stated420099Not determinedNone
Cipla Medpro (Pty) LtdCancelledPhenylephrine ciplaNot stated520466Not determinedNone
Umsebe healthcareHypopress0,1 mg/ml, 0.1/ 10mg/ml550352, 550353S4PIPIL
Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) LtdPhenpressor10 mg550361Not determinedPIPIL
Unimed Healthcare (Pty) LtdCertificate held by Lebasi Pharmaceuticals (Pty) LtdRusaine10 mg560060S1PIPIL
Equity Pharmaceutical (Pty) LtdPhenylephrine ps equity50 ug/ml570540Not determinedNone
RBC Pharmaceuticals (Pty) LtdPhenylephrine RBC10 mg/ml580131Not determinedNone
Accord Healthcare (Pty) LtdPhenylcord10 mg/ml590062Not determinedNone
Ruby Pharmaceuticals (Pty) LtdParipresNot stated590417Not determinedNone
Hetero Drugs South Africa (Pty) LtdPhenylephrine hetero100 mg/10 ml590460Not determinedNone
Fresenius Kabi Manufacturing SA (Pty) LtdPhenylephrine fresenius10 mg/1 ml590892Not determinedNone
Adcock ingram limitedCertificate held by Abbott Laboratories South Africa (Pty) Ltd1 of 2 cancelledPhenylephrine covan, Phenylephrine hydrochloride10 mg/mLF0011, LX0113S4PIPIL
Abbott Laboratories S.A. (Pty) LtdCertificate held by Abbott Laboratories South Africa (Pty) LtdPhenylephrine hydrochloride10 mg/mLH0630S4PIPIL
Specpharm Holdings (Pty) LtdEi-deelNot statedH1230Not determinedNone
The Premier Pharmaceutical Co LtdCancelledPhenylephrine eye, Optimed, Naphensyldrops, 0,25 %, 1 %H1307, H1310, H1403, H1596Not determinedNone
Pharmacare limited û woodmead3 of 4 cancelledSine off sinus, Phenylephrine hydrochloride nose, Eye-gene nf eyespray, drops, 1%J0066, L0137, L0138, X0132Not determinedNone
Abbvie (Pty) LtdCancelledPreferin liquifilm sterile eyedropsJ0084Not determinedNone
Boots Pharmaceuticals (Pty) LtdCancelledFenox nasalsprayZ0254Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Minims phenylephrine hydrochloride 2,5 %

EACH 0,5 ml EYE DROPS CONTAINS PHENYLEPHRINE HYDROCHLORIDE 12,50 mg

2,5 %31045831/15.4/0458CancelledNot determinedNone
Sudafed pe sinus decongestant

EACH TABLET CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

Not listed42009942/5.8/0099CancelledNot determinedNone
Phenylephrine cipla

Each injection contains: Phenylphrine

Not listed52046652/7.2/0466CancelledNot determinedNone
Hypopress 0,1 mg/ml

EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 0,1 mg

0,1 mg/mlSolution for injection or infusion55035255/6.1/0352Approved 10 May 2024RegisteredS4PIPIL
Hypopress 10 mg/ml

EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

0.1/ 10mg/mlSolution for injection or infusion55035355/6.1/0353Approved 9 November 2021RegisteredNot determinedPIPIL
Phenpressor 10 mg/ml

EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

10 mgInjection55036155/7.2/0361Approved 18 April 2023RegisteredNot determinedPIPIL
Rusaine 10 mg/ml

EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10, 0 mg

10 mgSolution for injection/infusion56006056/7.2/0060Approved 6 June 2023RegisteredS1PIPIL
Phenylephrine 50 ug/ml ps equity

Each 1,0 ml solution contains: Phenylephrine Hydrochloride equivalent to phenylephrine 50,0 ug

50 ug/ml57054057/6.1/0540RegisteredNot determinedNone
Phenylephrine 10 mg/ml RBC

EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

10 mg/ml58013158/7.2/0131RegisteredNot determinedNone
Phenylcord 10 mg/ml

EACH VIAL CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

10 mg/ml59006259/7.2/0062RegisteredNot determinedNone
Paripres

EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

Not listed59041759/7.2/0417RegisteredNot determinedNone
Phenylephrine 100 mg/10 ML hetero

EACH 10,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 100,0 mg

100 mg/10 ml59046059/7.2/0460RegisteredNot determinedNone
Phenylephrine 10 mg/1 ML fresenius

EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

10 mg/1 ml59089259/7.2/0892RegisteredNot determinedNone
Minims phenylephrine hydrochloride 10 %

EACH 100 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10 g

10 %D0022D/15.4/22RegisteredNot determinedNone
Phenylephrine covan

EACH 1 ml CONTAINS PHENYLEPHRINE 100 mg

Not listedF0011F/15.4/11CancelledNot determinedNone
Phenylephrine hydrochloride injection

EACH I ml CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 10 mg

10 mg/mLSolution for injection.H0630Approved 5 October 2022Old MedicineS4PIPIL
Ei-deel

EACH 10 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 0,01 g

Not listedH1230Old MedicineNot determinedNone
Phenylephrine eye drops

EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 1,0 mg

DropsH1307CancelledNot determinedNone
Optimed

EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 12,5 mg

Not listedH1310CancelledNot determinedNone
Naphensyl 1 %

EACH 10 ml CONTAINS :PHENYLEPHRINE HYDROCHLORIDE A 100 mg

1 %H1403CancelledNot determinedNone
Naphensyl 0,25 %

EACH 1 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 2,5 mg

0,25 %H1596CancelledNot determinedNone
Sine - off sinus spray

EACH 100 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 0,5 g

-SprayJ0066J/16.1/66CancelledNot determinedNone
Preferin liquifilm sterile eye drops

EACH 1 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 1,32 mg

DropsJ0084J/15.4/84CancelledNot determinedNone
Phenylephrine hydrochloride nose drops

EACH 15 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 37,5 mg

DropsL0137L/16.1/137CancelledNot determinedNone
Phenylephrine hydrochloride 1% nose drops

EACH 15 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 150,0 mg

1%DropsL0138L/16.1/138CancelledNot determinedNone
Phenylephrine hydrochloride injection

EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg

10 mg/mLSolution for injection.LX0113L/5.1/113Approved 5 October 2022RegisteredS4PIPIL
Eye-gene nf eye drops

EACH 1 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 1 mg

DropsX0132X/15.4/132RegisteredNot determinedNone
Fenox nasal spray

EACH 15 ml BOTTLE CONTAINS PHENYLEPHRINE 75,0 mg

SprayZ0254Z/16.1/254CancelledNot determinedNone

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing 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); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Phenylephrine hydrochloride

  • 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

  • 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

Pharmacological class: Cardiac stimulants. (class 6.1)

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

Hypopress 0,1 mg/ml, Umsebe healthcare is scheduled S4 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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