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McNeil Products Ltd

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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?

Summary of Product Characteristics last updated on the eMC: 25/07/2011
SPC Benadryl Plus Capsules

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 25/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Jul-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



To register a new, alternative name on the licence (change to section 1 of SPC)

Updated on 29/10/2010 and displayed until 25/07/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Oct-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Nature of change: Update to section 5.1 of the SPC to align with the 2 other acrivastine-containing products in the Benadryl range, with regards to the onset of action, as determined by the ability to antagonise histamine induced wheals and flares in the skin, which is 15 minutes.

Updated on 03/04/2008 and displayed until 29/10/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to MA as a result of integration
Updated on 21/04/2005 and displayed until 03/04/2008
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/09/2004 and displayed until 21/04/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 19/09/2002 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/08/2001 and displayed until 19/09/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   acrivastine
   pseudoephedrine hydrochloride