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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 14/11/2011
SPC Robitussin Dry Cough

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 14/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   22-Sep-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
6.5 Nature and Contents of Container

PET bottles containing 100ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap is also included.
Updated on 24/05/2011 and displayed until 14/11/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-May-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company








2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 5 ml of liquid contains;

 

Active ingredient:

Dextromethorphan Hydrobromide     7.5 mg

Excipients:

Ethanol (96%)

101 mg

Sodium

10.8 mg

Amaranth

0.165 mg

Liquid Maltitol

242 mg

Sorbitol Solution 70%

1.454 g

 

For a full list of ingredients, see 6.1


4.4       Special Warnings and Special Precautions for Use

This product contains 2.1 % w/v per 5 ml of ethanol (96%) which should be taken into consideration for those suffering from alcoholism, those who are pregnant or breastfeeding or high risk groups such as patients suffering from liver disease or epilepsy. 

This product contains amaranth (E123) which may cause allergic reactions.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

6.3       Shelf Life

 

PET Bottles: 3 years

 

 

6.5       Nature and Contents of Containers

 

PET bottles containing 100ml with PVdC lined PP child resistant screw caps

 

A clear polypropylene measuring cup is also included.
Updated on 11/08/2010 and displayed until 24/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER

Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.


(formally Wyeth Consumer Healthcare) 
Updated on 08/03/2010 and displayed until 11/08/2010
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 12/01/2007 and displayed until 08/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Update of section 4.4 (C2030281)
Updated on 23/08/2006 and displayed until 12/01/2007
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
Section 6.1: Remove referecence to BP1968
Updated on 01/02/2006 and displayed until 23/08/2006
Reasons for adding or updating:
  • 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
Updated on 30/03/2005 and displayed until 01/02/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 13/06/2003 and displayed until 30/03/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Dextromethorphan Hydrobromide