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HSA Approval

CLARITYN-D 12HOUR REPETABS

SIN07282P

CLARITYN-D 12HOUR REPETABS

CLARITYN-D 12HOUR REPETABS

November 6, 1992

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBAYER (SOUTH EAST ASIA) PTE LTD
Licence HolderBAYER (SOUTH EAST ASIA) PTE LTD

Product Classification

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

Formulation Information

TABLET, SUGAR COATED

**Dosage and administration** Adults and Children 12 years of age and over: One Clarityn-D® 12Hour Repetabs tablet twice a day.

ORAL

Medical Information

**Indications and usage** Clarityn-D® 12Hour Repetabs is indicated for the relief of symptoms associated with allergic rhinitis and the common cold including nasal congestion, sneezing, rhinorrhea, pruritus and lacrimation. Clarityn-D® 12Hour Repetabs is recommended when both the antihistaminic properties of loratadine and the decongestant effect of pseudoephedrine sulfate are desired.

**Contraindications** Clarityn-D® 12Hour Repetabs are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components, to adrenergic agents or to other drugs of similar chemical structure. Clarityn-D® 12Hour Repetabs are also contraindicated in patients receiving MAO inhibitor therapy or within 2 weeks of discontinuing such treatment and in patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.

R01BA52

pseudoephedrine, combinations

Manufacturer Information

BAYER (SOUTH EAST ASIA) PTE LTD

SAG Manufacturing SLU

Active Ingredients

PSEUDOEPHEDRINE SULPHATE

120 mg

Pseudoephedrine

LORATADINE

5 mg

Loratadine

Documents

Patient Information Leaflets

Clarityn-D 12 hour Repetabs PIL and PI.pdf

Approved: July 13, 2022

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