BENYLIN FOUR FLU 500/12.5/22.5 Milligram Film Coated Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
21-01-2017
Shusha Tabia za bidhaa (SPC)
20-05-2017

Viambatanisho vya kazi:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Inapatikana kutoka:

McNeil Healthcare (Ireland) Ltd

ATC kanuni:

N02BE51

INN (Jina la Kimataifa):

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Kipimo:

500/12.5/22.5 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Analgesics and antipyretics

Idhini hali ya:

Authorised

Idhini ya tarehe:

1998-06-02

Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Four Flu Film-Coated Tablets.
Paracetamol 500mg
Diphenhydramine hydrochloride 12.5mg
Pseudoephedrine hydrochloride 22.5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Diphenhydramine hydrochloride 12.5 mg
Paracetamol
500 mg
Pseudoephedrine hydrochloride 22.5 mg
Also contains:
Sunset yellow E110
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orange, oval, biconvex, film coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu; including
relief of nasal congestion and congestion of mucous
membranes of the upper respiratory tract, sneezing, runny nose,
coughing, fever, headache, muscular aches and pains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER:
Two tablets, up to four times daily, as required. Do not take more
frequently than every four hours.
CHILDREN 10 TO 15 YEARS
One tablet, up to four times daily, as required. Do not take more
frequently than every four hours.
Not to be used for
more than five days without the advice of a doctor.
Parents or carers should seek medical attention if the child’s
condition deteriorates during treatment.
CHILDREN UNDER 10 YEARS
Benylin Four Flu Tablets are contraindicated in children under the age
of 10 years (see section 4.3).
Do not exceed the stated dose.
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