BENYLIN DRY COUGHS SYRUP - DIPHENYDRAMINE HYDROCHLORIDE/DEXTROMETHORPHAN HYDROBROMIDE/LEVOMENTHOL 14/6.5/2 per 5ml %v/v Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, LEVOMENTHOL

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

R06AA52

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, LEVOMENTHOL

Dosage:

14/6.5/2 per 5ml %v/v

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Aminoalkyl ethers

Authorization status:

Authorised

Authorization date:

1992-09-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENYLIN DRY COUGHS SYRUP
Diphenhydramine hydrochloride 14 mg/5ml
Dextromethorphan hydrobromide 6.5 mg/5ml
Levomenthol 2 mg/5ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 5 days
WHAT IS IN THIS LEAFLET
1.
What Benylin Dry Coughs Syrup is and what it is used for
2.
What you need to know before you use Benylin Dry Coughs Syrup
3.
How to use Benylin Dry Coughs Syrup
4.
Possible side effects
5.
How to store Benylin Dry Coughs Syrup
6.
Contents of the pack and other information
1 WHAT BENYLIN DRY COUGHS SYRUP IS AND WHAT IT IS USED FOR
Benylin Dry Coughs is a medicine which is used to help relieve dry,
irritating coughs. The
liquid contains diphenhydramine hydrochloride which is an
antihistamine that helps relieve
coughing and dry secretions in the nose and chest, dextromethorphan
hydrobromide which is
an antitussive to help stop coughing 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 WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN DRY COUGHS SYRUP
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 BENYLIN DRY COUGHS SYRUP …
■ If you are allergic to diphenhydramine, dextromethorphan,
levomenthol or any of the
ingredients of this medicine (listed in section 6).
■ If you suffer from LUNG DISEASE.
■ If you are taking, or have taken in the last two weeks,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENYLIN Dry Coughs Syrup
Diphenydramine Hydrochloride 14mg/5ml
Dextromethorphan hydrobromide 6.5mg/5ml
Levomenthol 2mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains diphenhydramine hydrochloride 14 mg, levomenthol 2
mg and dextromethorphan hydrobromide 6.5
mg.
Excipients with known effect: Each 5 ml contains liquid glucose 3.49
g, sucrose 1g, ethanol (96%) 0.260 ml and
Ponceau 4R (E124) 250 micrograms.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A clear red syrup having a menthol-raspberry flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BENYLIN Dry Coughs is indicated as an antitussive, for the relief of
persistent, dry, irritating cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
10 ml syrup 3 to 4 times a day.
Maximum daily dose: 40 ml syrup
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
Normal adult dosage is appropriate, (see section 5.2).
HEPATIC DYSFUNCTION:
Due to the extensive hepatic metabolism of dextromethorphan, caution
should be exercised in the presence of hepatic
impairment. (see section 5.2).
RENAL DYSFUNCTION
It may be prudent to increase the dosage interval in subjects with
moderate to severe renal impairment, (see section
5.2).
METHOD OF ADMINISTRATION
For oral use only
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