PEPCID AC Film-coated tablet Ref.[7822] Active ingredients: Famotidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Product name and form

Pepcid AC 10mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Pale-rose, rounded-square, film-coated tablet with FA10 engraved on one side.

Qualitative and quantitative composition

Each tablet contains 10mg Famotidine.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Famotidine

Famotidine is a potent competitive H2-receptor antagonist. Famotidine has a rapid onset of action and, at the recommended doses, has a long duration of action and is highly effective at relatively low blood concentrations.
List of Excipients

Pregelatinised starch
Cellulose, microcrystalline
Talc
Magnesium stearate
Hydroxypropyl methylcellulose
Hydroxypropylcellulose
Titanium dioxide (E171)
Carnauba wax
Red ferric oxide (E172)

Pack sizes and marketing

PVC/PE/PVDC/Al blisters of 6, 12 and 18 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Marketing authorization dates and numbers

PA 330/53/1

Date of first authorisation: 24 September 1996
Date of last renewal: 24 September 2006

Drugs

Drug Countries
PEPCID Canada, Spain, Finland, Ireland, United States
 
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