ZYRTEC-D Prolonged release tablet Ref.[28275] Active ingredients: Cetirizine Pseudoephedrine

Source: Marketing Authorisation Holder  Revision Year: 2021  Publisher: Manufacturer tablets: UCB Farchim S.A., Z.I. de Planchy, 10 Chemin de Croix Blanche, CH-1630 Bulle, Switzerland Packager: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I 10044 Pianezza, Italy

Product name and form

Zyrtec-D.

Pharmaceutical Form

Prolonged release tablet is white to off-white, round biconvex film-coated tablet having a circular logo on one side.

Qualitative and quantitative composition

Each tablet contains 5 mg cetirizine dihydrochloride in an immediate release form and 120 mg pseudoephedrine hydrochloride in a prolonged-release form.

Active Ingredient Description
Cetirizine

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1-receptors. In vitro receptor binding studies have shown no measurable affinity for other than Η1-receptors.

Pseudoephedrine

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

List of Excipients

Hypromellose
Microcrystalline cellulose
Colloidal anhydrous silica
Magnesium stearate
Lactose monohydrate
Croscarmellose sodium
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

The tablets are packed in PVC-Aclar Rx 160/Aluminium foil blisters or child resistant OPA/Alu/PVCAlu/Paper blisters placed in a cardboard box containing 10 and 50 tablets.

Marketing authorization holder

Manufacturer tablets: UCB Farchim S.A., Z.I. de Planchy, 10 Chemin de Croix Blanche, CH-1630 Bulle, Switzerland

Packager: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I – 10044 Pianezza, Italy

Drugs

Drug Countries
ZYRTEC-D Cyprus, Ecuador, Hong Kong, Singapore

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