Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland
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. |
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 |
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.
Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland
PA1186/016/001
Date of first authorisation: 26th May 2017
Date of last renewal: 12th January 2022
| Drug | Countries | |
|---|---|---|
| NYTOL | Canada, Ecuador, Ireland, Malta, Mexico, United Kingdom |
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