Benylin Children’s Dry Coughs Syrup Diphenhydramine Hydrochloride 7mg/5ml Levomenthol 0.55mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levomenthol; Diphenhydramine hydrochloride

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R06AA; R06AA02

INN (International Name):

Levomenthol; Diphenhydramine hydrochloride

Dosage:

7mg/5ml + 0.55 mg/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Aminoalkyl ethers; diphenhydramine

Authorization status:

Marketed

Authorization date:

1992-08-24

Patient Information leaflet

■
This medicine is used to help relieve the symptoms
of cough and congestion and also for hayfever and
other allergic conditions.
■
This medicine is for use by children aged 6-12 years.
■
DO NOT GIVE YOUR CHILD THIS MEDICINE
:
■
There are some people who should not use this
medicine.
_To find out if your child is one of them see _
_section 2 _
■
If your child has ever had a bad reaction to any of the
ingredients.
_For the list of ingredients see section 6 _
■
SPEAK TO YOUR DOCTOR:
■
If your child suffers from any of the conditions
mentioned in section 2.
_See section 2 _
■
If your child is taking any other medicines.
_See _
_section 2 _
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
Children of different ages need different amounts.
_See _
_section 3 _
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE
. Keep the leaflet: you might need it again.
Ask your pharmacist if you need more information or advice.
Go to see your doctor if your child's symptoms worsen or
do not improve after a few days.
1 WHAT THE MEDICINE IS FOR
Benylin Children's Dry Coughs Syrup is a medicine
used to relieve the symptoms of cough and congestion
and also for hayfever and other allergic conditions. The
liquid contains diphenhydramine hydrochloride which is
an antihistamine that helps relieve coughing and dry
secretions in the nose and chest, and levomenthol which
helps you breathe more easily by relieving congestion.
The medicine is for use in children aged 6 to 12 years.
2 BEFORE GIVING YOUR CHILD THIS MEDICINE
This medicine is suitable for most children but a few
children should not use it. If you are in any doubt, talk
to your doctor or pharmacist.
X DO NOT GIVE YOUR CHILD THIS MEDICINE …
■
If s/he has ever had a
BAD REACTION
to this
product or any of the ingredients.
■
If your child is taking
ANY OTHER COUGH AND COLD
MEDICINE.
■ If your child is taking, or has taken in the last
two weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
■
If s/he is under 6 years.
If any of t

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2022
CRN00CQXJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Children’s Dry Coughs Syrup
Diphenhydramine Hydrochloride 7mg/5ml
Levomenthol 0.55mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Diphenhydramine Hydrochloride 7mg and Levomenthol 0.55mg in
each 5ml.
Excipient(s) with known effect: Each 5 ml contains:
Sorbitol 2.525g
Sodium 16.47mg
Ethanol 197mg
Sodium Benzoate (E211) 25mg
Propylene glycol (E1520) 1.07mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
Clear, colourless syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the symptomatic relief of non-productive cough and of allergic
conditions and reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHILDREN AGED 6 YEARS AND OVER:
Oral. 10 ml syrup 3 or 4 times a day.
Maximum daily dose: 40 ml syrup
Use only when simple measures have failed to provide adequate relief.
Use for more than five consecutive days is not recommended.
CHILDREN UNDER 6 YEARS:
Benylin Children’s Dry Coughs is not suitable for administration to
children under 6 years of age. [See Section 4.3]
THE ELDERLY:
Not applicable
HEPATIC & RENAL DYSFUNCTION
It may be prudent to increase the dosage interval in subjects with
moderate to severe hepatic and/or renal dysfunction, [See
Pharmacokinetics].
4.3 CONTRAINDICATIONS
Benylin Children's Dry Coughs is contraindicated in individuals with
hypersensitivity to diphenhydramine, levomenthol or to
any of the excipients listed in section 6.1.
Benylin Children's Dry Coughs is contraindicated in patients taking
Monoamine inhibitors (MAOIs) or within 14 days of
stopping treatment (see section 4.5)
Health Products Regulatory Authority
11 January 2022
CRN00CQXJ
Page 2 of 8
Benylin Children's Dry Coughs should not be used in children under the
age of 6 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benylin Children's Dry Coughs may cause drowsiness. Children receiving
the product should be carefully supervised i