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HSA Approval

COLIMIX SYRUP

SIN03333P

COLIMIX SYRUP

COLIMIX SYRUP

June 16, 1989

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAPEX PHARMA MARKETING PTE. LTD.
Licence HolderAPEX PHARMA MARKETING PTE. LTD.

Product Classification

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

Formulation Information

SYRUP

**Dosage** For oral administration only. Unless otherwise prescribed by the physician: Infants over 6 months: 5 ml before each feed. Do not exceed 4 doses in 24 hours.Children 4 to 12 years: 5 to 10 ml 4 times daily.Adults: 10 ml 3 to 4 times daily and at bedtime. Do not exceed the stated dose.

ORAL

Medical Information

**Actions and Uses** Infant colic: Babies drink very quickly and they swallow much air with their milk; especially when bottle-fed. If the air is not expelled (e.g. by burping), the bubbles get trapped in the digestive system. Painful spasms (colic) develop as the intestines try to expel the bubbles; and the baby cries without stopping. **Colimix** breaks up the bubbles and relaxes the intestinal muscles thus easing the pain and helping baby to burp. In older children and adults, **Colimix** is equally effective in relieving flatulence (wind) and abdominal discomfort due to entrapped gas.

**Contraindication** Dicyclomine is not recommended for use in infants under the age of six months.

A03ED

复方中有其它药物的解痉药

Manufacturer Information

APEX PHARMA MARKETING PTE. LTD.

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Active Ingredients

SIMETHICONE

50 mg/5 ml

Simethicone

DICYCLOMINE HCl

5 mg/5 ml

Dicyclomine

Documents

Package Inserts

Colimix Syrup PI.pdf

Approved: February 18, 2022

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COLIMIX SYRUP - HSA Approval | MedPath