Skip to content
SPC Logo

Benylin Day & Night Tablets

Last Updated on eMC 03-Mar-2016 View document  | McNeil Products Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 03-Mar-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 26-Feb-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1 Added following excipients to Film Coating "Hypromellose" "Indigo Carmine (E132)" "Titanium Dioxide (E171)"

Removed following excipients from Film Coating "Methocel E5 (E5 Premium)" "Opaspray M 1F 4315B"

Section 10 Replaced date with "26 February 2016"

Updated on 07-Jun-2010 and displayed until 03-Mar-2016

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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 10 date of revision of the text

Date of revision of text on the SPC: 27-May-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change: Variation to add an alternative name Sudafed Decongestant & Pain Tablets to the Benylin Day & Night Tablets licence.

Chnages to sections 1 (Name of the medicinal product), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) & 4.6 (Pregnancy and lactation) of the SPC.

Updated on 13-May-2009 and displayed until 07-Jun-2010

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 30-Apr-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Minor change to SPC section 6.5 (Container type)

Updated on 27-Jan-2009 and displayed until 13-May-2009

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 07-Jan-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Licence renewal (change to date of renewal and date of revision of text)

Updated on 03-Apr-2008 and displayed until 27-Jan-2009

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Mar-2008

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Updated on 14-Nov-2007 and displayed until 03-Apr-2008

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To replace the currently registered pack size of 20 tablets (15 day and 5 night tablets) with a pack size of 16 tablets (12 day and 4 night tablets).

Updated on 09-Nov-2007 and displayed until 14-Nov-2007

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: Change of the date of the revision of the text

Updated on 14-Sep-2005 and displayed until 09-Nov-2007

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 14-Sep-2005 and displayed until 14-Sep-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 13-Sep-2005 and displayed until 14-Sep-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 09-Sep-2005 and displayed until 13-Sep-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 08-Sep-2005 and displayed until 09-Sep-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 21-Apr-2005 and displayed until 08-Sep-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 24-Nov-2004 and displayed until 21-Apr-2005

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 29-Sep-2004 and displayed until 24-Nov-2004

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 07-Jan-2003 and displayed until 29-Sep-2004

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition

Updated on 16-Sep-2002 and displayed until 24-Sep-2002

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

diphenhydramine hydrochloride, paracetamol, pseudoephedrine hydrochloride

Legal categories

P - Pharmacy

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue