ZYRTEC Film-coated tablet / Oral drops / Oral solution Ref.[28326] Active ingredients: Cetirizine

Source: Health Sciences Authority (SG)  Revision Year: 2018  Publisher: Manufacturer for tablets: UCB FARCHIM SA, BULLE SWITZERLAND Manufacturer for oral solution and drops: AESICA PHARMCEUTICALS S.R.L., PIANEZZA (TO) – ITALY

Product name and form

Zyrtec.

Pharmaceutical Form

Film-coated tablets: White oblong film-coated tablets. Each tablet has a bisect line and a Y-Y logo.

Oral drops: The solution is clear and colourless.

Oral solution: The solution is clear and colourless with slightly sweet taste and a banana flavour.

Qualitative and quantitative composition

Zyrtec tablets, each containing 10 mg cetirizine dihydrochloride. It contains 66.40 mg lactose per film-coated tablet.

Zyrtec oral drops containing 10 mg cetirizine dihydrochloride per ml. It contains preservatives methylparaben 1.35 mg/ml and propylparaben 0.15 mg/ml.

Zyrtec oral solution containing 1 mg cetirizine dihydrochloride per ml. It contains preservatives methylparaben 1.35 mg/ml and propylparaben 0.15 mg/ml.

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.

List of Excipients

Zyrtec Tablet 10 mg:

Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate, Opadry Y-1-7000 which consists of, Hydroxypropylmethylcellulose (E464), Titanium dioxide (E171), Macrogol 400.

Zyrtec Oral Drops 10 mg/ml:

Glycerol (85%), Propylene glycol, Saccharin sodium, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium acetate, Glacial acetic acid, Purified water.

Zyrtec Oral Solution 1 mg/ml:

Sorbitol solution at 70% (non-crystallising), Glycerol (85%), Propylene glycol, Saacharin sodium, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Banana flavor 54.330/A, Sodium acetate, Glacial acetic acid, Purified water.

Pack sizes and marketing

Tablet: Boxes containing 10, 50 and 500 film-coated tablets in blister strips.

Oral drops: Bottle containing 10 or 20 ml drops.

Oral solution: Bottle containing 75 ml solution.

Not all presentations will be available locally.

Marketing authorization holder

Manufacturer for tablets: UCB FARCHIM SA, BULLE – SWITZERLAND

Manufacturer for oral solution and drops: AESICA PHARMCEUTICALS S.R.L., PIANEZZA (TO) – ITALY

Drugs

Drug Countries
ZYRTEC Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.