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HSA Approval

MUCODEX POWDER FOR SOLUTION 100MG/SACHET

SIN16305P

MUCODEX POWDER FOR SOLUTION 100MG/SACHET

MUCODEX POWDER FOR SOLUTION 100MG/SACHET

August 18, 2021

PHARMAZEN MEDICALS PTE LTD

PHARMAZEN MEDICALS PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARMAZEN MEDICALS PTE LTD
Licence HolderPHARMAZEN MEDICALS PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

POWDER, FOR SOLUTION

**How much and how often should you use this medicine?** Adults and children above 6 years 2 sachets Mucodex 100mg, 2–3 times a day or 1 sachet of Mucodex Powder for Solution 600mg a day (preferably in the evening) Children (2 – 6 years of age) 1 sachet Mucodex 100mg from 2 to 4 times a day, accordingly to the age. Dissolve the contents of the sachets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass. It is preferable not to mix other drugs with Mucodex solution. It is advisable to administer antibiotics 2 hours apart from Acetylcysteine. The duration of treatment should be 5 to 10 days. if you do not feel better or if you feel worse, you must talk to a doctor.

ORAL

Medical Information

**What is this medicine used for?** To loosen mucus and make it easier to cough up in respiratory tract conditions associated with sticky/thick mucus.

**When should you not take this medicine?** Do not take this medicine if you are allergic to acetylcysteine or to any excipients. The medicine should not be used in children below 2 years of age. Mucolytic agents can induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the ability to expectorate may be limited.

R05CB01

acetylcysteine

Manufacturer Information

PHARMAZEN MEDICALS PTE LTD

XL Laboratories Private Limited

Active Ingredients

Acetylcysteine

100mg/sachet

Acetylcysteine

Documents

Patient Information Leaflets

Mucodex 100mg 600mg Patient Information Leaflet July 2021.pdf

Approved: August 18, 2021

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MUCODEX POWDER FOR SOLUTION 100MG/SACHET - HSA Approval | MedPath