ATARAX Film-coated tablets Ref.[7284] Active ingredients: Hydroxyzine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Product name and form

Atarax 10mg Film-coated tablets.

Pharmaceutical Form

10mg film-coated tablets, coloured orange and coded on one side with ‘AX’.

Qualitative and quantitative composition

Hydroxyzine hydrochloride 10mg.

Excipient(s) with known effect:

Lactose (anhydrous) 47.3mg

Sunset Yellow (E110) 0.24mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Hydroxyzine

Hydroxyzine is a first generation antihistamine, a piperazine derivative, with antimuscarinic and sedative properties.

List of Excipients

Tablet core:

Lactose anhydrous
Calcium phosphate dibasic anhydrous
Pregelatinised starch
Magnesium stearate
Sodium lauryl sulfate
Silicon dioxide

Tablet coating:

Opadry II Orange 85G23730 (10mg only) - contains:

Poly (vinyl alcohol)
Talc
Macrogol 3350
Sunset yellow (E110)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Quinoline yellow (E104)
Lecithin (E322)

Pack sizes and marketing

White opaque 250/51 micron PVC/PCTFE (Aclar) - 20 micron aluminium foil blister strips containing 84 × 10mg tablets, (6 blister strips per carton).

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Marketing authorization dates and numbers

PL 16853/0094

27 April 1987/30 July 1997

Drugs

Drug Countries
ATARAX Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Japan, Malta, Mexico, Poland, Singapore, Tunisia, Turkey

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