Benylin Day and Night Tablets
- Name:
Benylin Day and Night 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: 14/12/20

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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 16 December 2020 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 14 December 2020 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 December 2020 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 2 December 2019 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 2 December 2019 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 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 26 November 2019 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category: Supply through pharmacy only
Updated on 20 August 2019 PIL
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 12 November 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 November 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 11 July 2018 SPC
Reasons for updating
- 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 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 11 July 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 21 July 2011 PIL
Reasons for updating
- New PIL for new product
Updated on 21 July 2011 PIL
Reasons for updating
- Improved electronic presentation
Updated on 1 October 2010 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 29 September 2010 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 29 September 2010 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 13 August 2010 SPC
Reasons for updating
- 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
Updated on 12 August 2010 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 7 April 2009 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 7 April 2009 PIL
Reasons for updating
- Change to date of revision
- Change of trade or active ingredient name
Updated on 25 August 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 March 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
Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24
Updated on 24 August 2007 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
section 6.4 chagned to Do not store above 25°C. Store in original container.
Updated on 28 February 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only