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HSA Approval

FEDAC COMPOUND LINCTUS

SIN03195P

FEDAC COMPOUND LINCTUS

FEDAC COMPOUND LINCTUS

June 1, 1989

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantTEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Licence HolderTEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

ELIXIR

**RECOMMENDED DOSAGE:** Adults and children over 12 years: 2 teaspoonfuls 3 times a day **Children and Adolescents:** Codeine should not be used in children below 12 years old. In those 12 years old and above, codeine may be used for the treatment of unproductive cough which is not relieved by other anti-tussives alone. The lowest effective dose should be used for the shortest possible duration.

ORAL

Medical Information

**INDICATIONS:** Temporary relief of coughs and upper respiratory symptoms including nasal congestion associated with allergy or the common cold.

**CONTRA-INDICATIONS:** In patients intolerant to Pseudoephedrine HCI or Triprolidine HCI or Codeine Phosphate. Patients with severe hypertension, severe coronary artery disease and in patients on MAO inhibitors. FEDAC COMPOUND LINCTUS should not be used in newborn or premature infants and should not be used to treat lower respiratory tract symptoms including asthma.

R05DA20

combinations

Manufacturer Information

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ICM PHARMA PTE. LTD.

Active Ingredients

PSEUDOEPHEDRINE HCl

30 mg/5 ml

Pseudoephedrine

CODEINE PHOSPHATE

10 mg/5 ml

Codeine

TRIPROLIDINE HCl

1.25 mg/5 ml

Triprolidine

Documents

Package Inserts

Att 4 AAAO2079 Fedac Compound Linctus PIL, SG_03 Proposed.pdf

Approved: June 10, 2022

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