Benylin Dry Coughs Syrup Diphenhydramine hydrochloride 14mg/5ml Dextromethorphan hydrobromide 6.5mg/5ml Levomenthol 2mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diphenhydramine hydrochloride; Dextromethorphan hydrobromide; Levomenthol

Available from:

JNTL Consumer Health I (Ireland) Limited

ATC code:

R06AA; R06AA52

INN (International Name):

Diphenhydramine hydrochloride; Dextromethorphan hydrobromide; Levomenthol

Pharmaceutical form:

Syrup

Therapeutic area:

Aminoalkyl ethers; diphenhydramine, combinations

Authorization status:

Marketed

Authorization date:

1987-09-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Dry Coughs Syrup
DIPHENHYDRAMINE HYDROCHLORIDE 14 MG/5 ML
DEXTROMETHORPHAN HYDROBROMIDE 6.5 MG/5 ML
LEVOMENTHOL 2 MG/5 ML
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.
This medicine can lead to dependence. Therefore the treatment
should be of short duration. DO NOT USE BENYLIN DRY COUGHS SYRUP
If you are allergic to diphenhydramine, dextromethorphan,
levomenthol or any of the other ingredients of this medicine
(listed in section 6).
If you suffer

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2024
CRN00DGNW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Dry Coughs Syrup Diphenhydramine 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 5ml contains liquid glucose 3.50 g,
sucrose 1 g, invert sugar 6.75mg, ethanol (96%) 0.260 ml,
sodium benzoate 10 mg, benzyl alcohol 0.48 mg, propylene glycol
(E1520) 2.605mg, sodium 16.7mg 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.
4.3 CONTRAINDICATIONS
Benylin Dry Coughs is contraindicated in individuals with known
hypersensitivity to diphenhydramine, dextromethorphan,
levomenthol or to any of the excipients listed in section 6.1.
Health Products Regulatory Authority
28 March 2024
CRN00DGNW
Page 2 of 10
Benylin Dry Coughs is contraindicated in individuals who are taking,
or have taken, monoamine oxidase inhibi