Benylin Cough Medicine Syrup Diphenhydramine hydrochloride 14mg/5ml Levomenthol 1.1mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diphenhydramine hydrochloride; Levomenthol

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R06AA; R06AA02

INN (International Name):

Diphenhydramine hydrochloride; Levomenthol

Dosage:

14 mg/5 ml + 1.1 mg/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Aminoalkyl ethers; diphenhydramine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

■
This medicine can be used to relieve coughing and for
the relief of allergic conditions and reactions.
■
This medicine is for use by adults and children aged 12
years and over.
■
DO NOT USE 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 you have ever had a bad reaction to any of the
ingredients.
_For the list of ingredients see section 6 _
■
SPEAK TO YOUR DOCTOR:
■
If you suffer 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.
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 Cough Medicine is a medicine which is used to
relieve coughing and for the relief of allergic conditions and
reactions.The liquid contains diphenhydramine 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 adults and children aged
12 years and over.
2 BEFORE GIVING YOUR CHILD THIS MEDICINE
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk
to your doctor or pharmacist.
X DO NOT USE THIS MEDICINE …
■
If you have ever had a
BAD REACTION
to any of the ingredients.
If any of these apply,
GET ADVICE FROM A DOCTOR OR
PHARMACIST WITHOUT USING BENYLIN COUGH MEDICINE.
! TALK TO YOUR DOCTOR OR PHARMACIST…
■ If you suffer from
LIVER
or
KIDNEY PROBLEMS
■ If you suffer from
ASTHMA
,
A PERSISTENT COUGH
that may
be caused by smoking, chronic bronchitis or emphysema, or
a cough which brings up a lot of mucus (phlegm).
■ If you have
PROSTATE PROBLEMS
(difficulty wi

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 Cough Medicine Syrup
Diphenhydramine hydrochloride 14mg/5ml
Levomenthol 1.1mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Diphenhydramine hydrochloride 14 mg
Levomenthol 1.1 mg
Excipient(s) with known effect: Each 5 ml contains:
Glucose Syrup 3.5g
Sucrose 1.0g
Ethanol 197mg
Ponceau 4R (E124) 0.25mg
Sodium 16.42mg
Sodium benzoate (E211) 10mg
Invert sugar 6.75mg
Propylene glycol (E1520) 1.05mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
Clear red syrup with a taste characteristic of menthol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(a)
Properties
Fixed combination of anti-histamine with anti-tussive activity and
carminative.
(b)
Indications for use
In the symptomatic relief of non-productive cough and of allergic
conditions and reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN OVER 12 YEARS:
One or two 5 ml spoonfuls three to four times daily.
Not recommended for children under 12 years. [see section 4.3]
Health Products Regulatory Authority
11 January 2022
CRN00CQXJ
Page 2 of 8
4.3 CONTRAINDICATIONS
Benylin Cough Medicine is contraindicated in individuals with
hypersensitivity to diphenhydramine, levomenthol or to any of
the excipients listed in section 6.1.
Benylin Cough Medicine should not be used in children under the age of
12 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use with any other product containing diphenhydramine, even one
used on skin (see Section 4.5).
Patients with moderate to severe renal or hepatic dysfunction should
exercise caution when using this product (see Section 5.2).
Patients with the following conditions should be advised to consult a
physician before using Benylin Cough Medicine:

Acute or chronic bronchial asthma, a persistent or chronic cough such
as occurs with smoking, chronic bronchitis
or emphysema or where cough i