Benylin Four Flu Tablets
- Name:
Benylin Four Flu Tablets
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/09/20

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Johnson & Johnson (Ireland) Ltd
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Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 18 September 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 18 September 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 December 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 23 December 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 13 September 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 September 2019 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 5 December 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 5 December 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 19 January 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
For oral use
Adults, the elderly and children aged 12
16 years and over:
Two tablets, up to four times daily, as required. Do not take more
frequently than every four hours
Children 6
10 to 12 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 6
10 years
Benylin Four Flu Tablets are contraindicated in children under the age
of 6
10 years (see section 4.3).
Do not exceed the stated dose.
4.3 Contraindications
Known hypersensitivity to diphenhydramine, paracetamol,
pseudoephedrine or to any of the excipients.
Concomitant use of other sympathomimetic agents including those
given by other routes, beta-blockers (see section 4.5) and monoamine
oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI
treatment (see section 4.5)
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Severe renal impairment
Not to be used in children under the age of 6
10 years.
10 DATE OF REVISION OF THE TEXT
06-January-2017
Updated on 19 January 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 13 January 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 13 January 2017 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 8 April 2013 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 21 July 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 21 July 2011 PIL
Reasons for updating
- Change of manufacturer
Updated on 2 June 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 1 June 2010 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 25 August 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 22 August 2008 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2006 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 4 October 2004 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Supply through pharmacy only
Updated on 30 September 2004 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Supply through pharmacy only
Updated on 28 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 11 August 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only