Ammonium chloride, codeine, diphenhydramine
Sold as Expectalin with codeine, Benylin forte, Flutex co, Histalix, Benylin with codeine
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Johnson & Johnson (Pty) Ltd û East LondonCertificate held by Johnson &Amp; Johnson (Pty) Ltd | Expectalin with codeine, Benylin with codeine | 5 mL | 280249, G0830 | S2 | PIPIL |
| Johnson & Johnson (Pty) Ltd û Cape TownCertificate held by Johnson & Johnson (Pty) Ltd | Benylin forte | 12.5 mg, 10 mg, 125 mg | 560570 | S2 | PIPIL |
| Pharmacare limited û woodmead | Flutex co | linctus | F0162 | Not determined | None |
| Bayer (Pty) Ltd û Isando | Histalix | Not stated | G0561 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Expectalin with codeine* EACH 5 ml LIQUID CONTAINS AMMONIUM CHLORIDE 125 mg CODEINE PHOSPHATE 10 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | 5 mLLiquid. | 28024928/10.1/0249Approved 12 July 2024 | Registered | S2 | PIPIL |
| Benylin forte EACH 5,0 ml SYRUP CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg CODEINE PHOSPHATE 10,0 mg AMMONIUM CHLORIDE 125,0 mg | 12.5 mg, 10 mg, 125 mgSyrup | 56057056/10.1/0570Approved 8 October 2024 | Registered | S2 | PIPIL |
| Flutex co linctus EACH 5 ML CONTAINS AMMONIUM CHLORIDE 100 mg CODEINE PHOSPHATE 7,5 mg DIPHENHYDRAMINE HYDROCHLORIDE 12 mg | Linctus | F0162F/10.1/162 | Registered | Not determined | None |
| Histalix 5 ML AMMONIUM CHLORIDE A 90 MG CODEINE PHOSPHATE A 9 MG DIPHENHYDRAMINE HYDROCHLORIDE A 10 MG | Not listed | G0561 | Old Medicine | Not determined | None |
| Benylin with codeine EACH 5,0 ml LIQUID AMMONIUM CHLORIDE A 125,0 mg CODEINE PHOSPHATE A 10,0 mg DIPHENHYDRAMINE HYDROCHLORIDE A 12,50 mg | Not listed | G0830 | Old Medicine | Not determined | None |
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.
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 Verification
Expectalin with codeine*, Johnson & Johnson (Pty) Ltd û East London 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.