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Wyeth Consumer Healthcare

Wyeth Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin, 24
Telephone: +353 1 467 6500
Telephone: Medical Information Contact: +353 1 467 6627
Fax: +353 1 467 6501
Summary of Product Characteristics last updated on medicines.ie: 08/03/2010
SPC Robitussin Plus

When a pharmaceutical company changes an SPC or PIL, 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 08/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   24-Nov-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.2 the posology for children under 12 has been removed.
Section 4.3 the product is no longer recommended for children under 12 years of age
Updated on 26/03/2008 and displayed until 08/03/2010
Reasons for adding or 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
Date of revision of text on the SPC:   02/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.2, Posology now states that, Patients should be advised to consult a pharmacist/doctor before using in children under 6 years of age.
Section 4.3, Contraindications  now states, Not recommended for children under 2 years of age.
Section 4.4, Special Warnings and Precautions states, If symptoms persist for more than 5 days consult a doctor. 
 
Updated on 29/01/2007 and displayed until 26/03/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.1 now includes following for natural cherry flavour
* contains Ethanol, Propylene Glycol and Natural Cherry Flavour
Updated on 18/08/2006 and displayed until 29/01/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   08/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Updated of Section 6.1 - INNs
Updated on 30/03/2005 and displayed until 18/08/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 11/06/2003 and displayed until 30/03/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Guaifenesin
   Pseudoephedrine Hydrochloride

Versions

 
08/03/2010 to Current
26/03/2008 to 08/03/2010
29/01/2007 to 26/03/2008
18/08/2006 to 29/01/2007
30/03/2005 to 18/08/2006
11/06/2003 to 30/03/2005
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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