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
Prescription Only
HSA Singapore Classification
Formulation Information
SYRUP
RECOMMENDED DOSAGE: Tablets:Adults and children over 12 years: 8 mg (1 tablet) 3 times a dayChildren :6 to 12 years: 4 mg (half tablet) 3 times a daySyrup:Adults and children over 12 years: 8 mg (10ml) 3 times a dayChildren :6 to 12 years: 4 mg (5ml) 3 times a day2 to 6 years: 4 mg (5ml) 2 times a day
ORAL
Medical Information
INDICATIONS: For the reduction of sputum viscosity.
CONTRA-INDICATIONS: Known hypersensitivity to bromhexine.
R05CB02
bromhexine
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
PT.ACTAVIS INDONESIA
Active Ingredients
Documents
Package Inserts
Att 2 AAAN4186 Vas PI P.pdf
Approved: June 25, 2021