Robitussin Chesty Cough
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 July 2024
File name
ie-working-spc-Robitussin Chesty Cough-GDSv4.0-PCH-harmonisation-240611MW-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through general sale
Updated on 22 July 2024
File name
ie-working-pil-Robitussin Chesty Cough-GDSv4.0-PCH-harmonisation-240611MW-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 July 2024
File name
ie-working-pil-Robitussin Chesty Cough-GDSv4.0-PCH-harmonisation-240611MW-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 March 2024
File name
ie-spc-robitussin-chesty-separation-231121MW-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 28 November 2023
File name
ie-working-pil-robitussin-chesty-separation-231121MW-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Change in MAH name from GSK to Haleon
Updated on 28 November 2023
File name
ie-working-pil-robitussin-chesty-separation-231121MW-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change of Marketing Authorisation Holder name from GSK to Haleon
Updated on 10 July 2023
File name
ie-spc-robitussin-chesty cough_jul_2023.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated due to site transfer activities - container and pack sizes have changed, and description of product (please note there has been no reformulation).
Updated on 10 July 2023
File name
ie-pil-text-robitussin-chesty cough_jul_2023.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Introduction of new pack/pack size
Free text change information supplied by the pharmaceutical company
Updated due to site transfer activities including change to pack size and description of the product (please note the formulation is not changing).
Updated on 23 February 2021
File name
1531_SmPC_Robitussin Chesty Cough_20_337_v3_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 23 February 2021
File name
1531_PIL_Robitussin Chesty Cough_20_337_v3 clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 10 December 2020
File name
1531_PIL_20 026 v1_PAA152588.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 10 December 2020
File name
1531_SmPC_20_026_v1_CLEAN.pdf
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
- Company name change or merger
Legal category:Supply through general sale
Updated on 07 October 2020
File name
1701_SmPC_19_149 v2.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 06 August 2020
File name
1701_SmPC_19_151_v1.pdf
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update Summary of Product Characteristics, Labelling or Package Leaflet due to new pharmacovigilance data & Include update to add Aprilia as a manufacturer to the PIL |
Updated on 06 August 2020
File name
1701_PIL_19 140v1_medicines ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Update Summary of Product Characteristics, Labelling or Package Leaflet due to new pharmacovigilance data & Include update to add Aprilia as a manufacturer to the PIL |
Updated on 04 November 2019
File name
1701_PIL_19_127_medicines ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 12 May 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 12 May 2016
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 10 was updated with the date of revision
Updated on 10 May 2016
File name
PIL_8450_52.pdf
Reasons for updating
- New PIL for new product
Updated on 10 May 2016
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 19 March 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 10 July 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 01 May 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update to section 4.8 to include the addition of reporting suspected adverse reactions information statement. This is a requirement of the latest QRD template.
Section 10 has consequently been updated due to these changes (now April 2014).
Updated on 15 August 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24.
8. MARKETING AUTHORISATION NUMBER
PA 822/170/1
10. DATE OF REVISION OF THE TEXT
August 2013
Updated on 13 August 2013
Reasons for updating
- Change of licence holder
Updated on 04 March 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Each 5 ml contains 100 mg guaifenesin
This product also contains ethanol (107mg per 5ml), maltitol (E965) and sorbitol (E420).
4.4. Special Warnings and Precautions for Use
This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
Updated on 01 March 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 20 November 2012
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 08 September 2012
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 14 November 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
PET bottles containing 100ml with PET lined PP/HDPE screw caps.
A clear polypropylene measuring cap is also included.
Updated on 11 May 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
New Text as follows;
4.1 Therapeutic Indications
Expectorant used as an adjunct in the treatment of productive cough
4.4. Special Warnings and Precautions for Use
Caution should be exercised in patients with chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.
A doctor or healthcare professional should be sought if cough lasts more than 5 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
4.8 Undesirable Effects
Immune system disorders |
Hypersensitivity |
Gastrointestinal disorders |
Nausea, vomiting |
4.9 Overdose
In case of accidentally overdose, discontinue use and seek professional assistance immediately.
The following signs and symptoms may be associated with an overdose of Guaifenesin:
Gastrointestinal disorders
Nausea, vomiting
Updated on 10 May 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
Updated on 11 August 2010
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.
(formally Wyeth Consumer Healthcare)
Updated on 09 August 2010
Reasons for updating
- Change to marketing authorisation holder
- Change of distributor details
Updated on 04 March 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.3 the product is no longer recommended for children under 12 years of age.
Updated on 03 March 2010
Reasons for updating
- Change of contraindications
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 05 May 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.4 (Special Warnings and precautions for use) now states; Not more than 4 doses should be given in 24 hours. Do not exceed the stated dose. This product should not be taken with any other cough and cold medicine.
Section 6.1 (List of excipients) E numbers have been stated after Sodium benzoate (E211) and Maltitol (E965) and Sorbitol (E420).
Section 6.5 (Nature and content of container) removed, glass bottle. which had a shelf life of 5 years (Section 6.3). Not marketed in this type of container.
Section 10 (Revision of Date) states October 2008.
Updated on 30 April 2009
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to further information section
Updated on 28 May 2008
Reasons for updating
- Addition of manufacturer
- Change to date of revision
- Change to dosage and administration
- Change to warnings or special precautions for use
Updated on 26 March 2008
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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.3, Contraindications now states, not recommended for children under 2 years of age.
Updated on 16 April 2007
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2006
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 30 March 2005
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 30 March 2005
Reasons for updating
- Change to packaging
Updated on 23 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 18 August 2004
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Updated on 11 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale