Codeine, pseudoephedrine, triprolidine (Fludactil Co, Endcol Cough)
Codeine, pseudoephedrine, triprolidine
Pharmacare limited û woodmead
Registration
- Applicant
- Pharmacare limited û woodmead
- Registrations
- 2
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fludactil co linctus EACH 5 ML CONTAINS CODEINE PHOSPHATE 10 MG PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG TRIPROLIDINE HYDROCHLORIDE 1,25 MG | Linctus | 30004930/5.8/0049 | Registered | Not determined | None |
| Endcol cough linctus EACH 5 ML CONTAINS CODEINE PHOSPHATE 10 MG PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG TRIPROLIDINE HYDROCHLORIDE 1,25 MG | Linctus | T0235T/10.1/235 | Cancelled | Not determined | None |
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
S6: Codeine
- single component codeine preparations;
- oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3)
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3)
Consolidated Schedules 06 July 2026, lines 10128 to 10136
S6: Pseudoephedrine
- except contained in products registered in terms of the Act, and not intended for export, being oral preparations and mixtures containing not more than 60 milligrams or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S2)
Consolidated Schedules 06 July 2026, lines 10412 to 10417
S3: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 3350 to 3372
S2: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days, and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit; (S3)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit; (S3)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 1758 to 1778
S2: Pseudoephedrine
- contained in products registered in terms of the Act, and not intended for export,
- Immediate-release oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine per dose or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S6)
Consolidated Schedules 06 July 2026, lines 2600 to 2607
S2: Triprolidine
Consolidated Schedules 06 July 2026, line 2745
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.