LEVOCABASTINE HYDROCHLORIDE Eye drops, Nasal spray Ref.[9896] Active ingredients: Levocabastine

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2020  Publisher: Johnson & Johnson Pacific, AUSTRALIA NEW ZEALAND, 45 Jones Street, Ultimo NSW 2007, Registered Trademark Consumer Care Centre Australia: 1800 029 979, New Zealand: 0800 446 147, Overseas Customers: +61 ...

Product name and form

Levocabastine hydrochloride.

Pharmaceutical Form

Eye drops: a sterile white ophthalmic microsuspension (pH 6-8)

Nasal spray: a white microsuspension (pH 6-8).

Qualitative and quantitative composition

Zyrtec eye drops

Active ingredients: levocabastine hydrochloride equivalent to levocabastine 0.5 mg/mL

Excipients with known effect: benzalkonium chloride and disodium edetate (both 0.15 mg/mL) as preservatives

Excipients: propylene glycol, polysorbate 80, sodium phosphate dibasic, sodium phosphate monobasic, hypromellose and water as inactive excipients.

Zyrtec nasal spray

Active ingredients: levocabastine hydrochloride equivalent to levocabastine 0.5 mg/mL

Excipients with known effect: benzalkonium chloride and disodium edetate (both 0.15 mg/mL) as preservatives

Excipients: propylene glycol, polysorbate 80, sodium phosphate dibasic, sodium phosphate monobasic, hypromellose and water as inactive excipients.

Active Ingredient Description
Levocabastine

Levocabastine is a potent, fast-acting and highly selective histamine H1-antagonist with a sustained duration of action.

List of Excipients

Refer to Section 2 – Qualitative and quantitative composition

Pack sizes and marketing

ZYRTEC eye drops: 4 mL in 5 mL bottle.

ZYRTEC nasal spray: 10 mL in 15 mL bottle.

Marketing authorization holder

Johnson & Johnson Pacific, AUSTRALIA – NEW ZEALAND, 45 Jones Street, Ultimo NSW 2007, Registered Trademark

Consumer Care Centre – Australia: 1800 029 979, New Zealand: 0800 446 147, Overseas Customers: +61 2 8260 8366

Marketing authorization dates and numbers

March 1994

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