ZELARY Film-coated tablet Ref.[115280] Active ingredients: Cetirizine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, Johannesburg, 2193, Tel: +27 11 611 1400 or +27 860 287 835

Product name and form

ZELARY 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

ZELARY 10 mg tablets: White, circular biconvex film-coated tablets with a score line on one side. The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

Contains sugar: lactose monohydrate 105 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Tablet core:

Maize starch
Lactose monohydrate
Povidone polyvinyl pyrrolidone (Kollidon K30)
Magnesium stearate

Tablet coat:

Hypromellose (Hydroxypropyl methylcellulose)
Propylene glycol
Titanium dioxide (C.I. No. 77891) (Anatase)
Talc

Pack sizes and marketing

ZELARY 10 tablets are packed in PVC/PVDC Aluminium Blister.

The tablets are packed in blisters of 10’s.

The pack sizes are 1 × 10 and 3 × 10’s in a unit carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, Johannesburg, 2193, Tel: +27 11 611 1400 or +27 860 287 835

Marketing authorization dates and numbers

37/5.7.1/0428

02 July 2004

Drugs

Drug Countries
ZELARY 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.