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
SYRUP
**RECOMMENDED DOSAGE:** Tablets: Adults and Children more than 12 years: 1 to 2 tablets, 3 or 4 times a day. Syrup: Children: 6 to 12 years: 2 teaspoonfuls 3 times a day.
ORAL
Medical Information
**INDICATION:** For relief of gastro-intestinal and colonic spasm, acute spasm in renal or biliary colic; dysmenorrhoea.
**CONTRA-INDICATIONS:** Contra-indicated in patients with glaucoma; with gastric or duodenal ulcer, with urinary retention; prostatic enlargement; paralytic ileus; pyloric stenosis.
A03BB01
butylscopolamine
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
PT ACTAVIS INDONESIA
Active Ingredients
Documents
Package Inserts
ATT4N6~2.PDF
Approved: December 22, 2021