Robitussin Chesty Cough

Product Information *

  • Company:

    GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through general sale

When a pharmaceutical company changes any document, 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 23 February 2021

File name

1531_SmPC_Robitussin Chesty Cough_20_337_v3_clean_1614098762.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_1614098600.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_1607613972.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_1607613903.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_1602064384.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_1596736898.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_1596736852.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_1572886311.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 4.8 was updated with HPRA reporting information
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

7. MARKETING AUTHORISATION HOLDER
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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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

Only typographical errors revised, no change to medical/pharmaceutical information. 

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

6.3 Shelf Life reduction from 36 months to 27 months.  

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

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 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

7. MARKETING AUTHORISATION HOLDER
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 4.2 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 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 2 (Qualitative and Quantitive composition), now states the product contains ethanol (103mg/5ml), maltitol (E965) and sorbitol (E420). 

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 4.2, 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 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

Update 6.1 -  Natural cherry flavourings - ethanol, propylene glycol and natural flavorings

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

Section 10: Include revision date

Updated on 30 March 2005

Reasons for updating

  • Change to packaging

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 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