HISTERGAN Coated tablet Ref.[27731] Active ingredients: Diphenhydramine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom

Product name and form

When sold as an antihistamine:

Histergan Tablets

When sold as a sleep aid:

Paxidorm Tablets 25mg
Numark Night Time Sleep Aid Tablets
NightAid
Aspar Sleep Aid 25 mg Tablets
Tor Generics Sleep Aid 25mg Tablets
Oberon Sleep Aid 25mg Tablets
EM Pharma Sleep Aid 25mg Tablets

Pharmaceutical Form

Pink sugar coated tablets.

Qualitative and quantitative composition

Diphenhydramine Hydrochloride 25mg.

Excipients with known effects:

Lactose
Sucrose

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

Lactose
Corn starch
Povidone
Magnesium stearate
Opaseal (polyvinyl acetate phthalate, ethyl acetate and stearic acid)
Sucrose
Calcium carbonate
Talc
Acacia
Titanium dioxide E171
Opalux Pink AS 1537 (E127 erythrosine)
Opaglos 6000 (carnauba wax, beeswax)
Silicone fluid

Pack sizes and marketing

Blister packs of 8, 16 and 20 tablets.

Marketing authorization holder

Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom

Marketing authorization dates and numbers

PL 00386/5008R

08 September 1989 / 14 June 1995

Drugs

Drug Countries
HISTERGAN Cyprus, Hong Kong, United Kingdom

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