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HSA Approval

POLARINE TABLET

SIN07612P

POLARINE TABLET

POLARINE TABLET

January 18, 1994

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSUNWARD PHARMACEUTICAL PRIVATE LIMITED
Licence HolderSUNWARD PHARMACEUTICAL PRIVATE LIMITED

Product Classification

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

Formulation Information

TABLET

**Dosage:** Tablet :Adults:One tablet three times daily.Syrup :Children 6 to 12 years:Half teaspoonful 6 hourly.Adults:One teaspoonful 6 hourly.

ORAL

Medical Information

**Indications:** It is indicated in nasal and respiratory congestion, common cold, acute sinusitis, allergic rhinitis.

**Contraindications:** This formula is contraindicated in patients exhibiting hypersensitivity to any of the components. Antihistamine are contraindicated in patients receiving monoamine oxidase inhibitors since these agents prolong and intensify the anticholinergic effects of anti-histamines. Antihistamines should not be used to treat lower respiratory tract symptoms. Sympathomimetic preparations are contraindicated in patients with severe hypertension, severe coronary artery disease and patients receiving MAO inhibitor therapy due to potentiation of the pressor effects of pseudoephedrine.

R06AB52

dexchlorpheniramine, combinations

Manufacturer Information

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

SUNWARD PHARMACEUTICAL SDN BHD

Active Ingredients

PSEUDOEPHEDRINE HCl

60 mg

Pseudoephedrine

DEXCHLORPHENIRAMINE MALEATE

2 mg

Documents

Package Inserts

Polarine Tablet.pdf

Approved: January 14, 2022

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POLARINE TABLET - HSA Approval | MedPath