NYTOL ONE-A-NIGHT Tablet Diphenhydramine Ref.[7713] Active ingredients: Diphenhydramine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland

Product name and form

Nytol One-A-Night 50 mg Tablets.

Pharmaceutical Form

Tablet.

A white to off white, 15 mm in length, oblong capsule-shaped tablet, embossed with “N50” logo on both sides.

Qualitative and quantitative composition

Each tablet contains 50 mg Diphenhydramine Hydrochloride (equivalent to 43.8 mg Diphenhydramine base).

Excipients with known effect: 168.75 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Diphenhydramine

Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors. Diphenhydramine is effective in reducing sleep onset (i.e., time to fall asleep) and increasing the depth and quality of sleep.

List of Excipients

Anhydrous lactose
Stearic acid
Microcrystalline cellulose
Colloidal anhydrous silica
Maize starch

Pack sizes and marketing

Nytol One-A-Night 50 mg Tablets are packaged into rigid UPVC/PVdCblister packs with a heat sealable aluminium foil. Strips of 4, 8, 10, 16 or 20 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland

Marketing authorization dates and numbers

PA1186/016/001

Date of first authorisation: 26th May 2017
Date of last renewal: 12th January 2022

Drugs

Drug Countries
NYTOL Canada, Ecuador, Ireland, Malta, Mexico, United Kingdom

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