Benylin Children's Chesty Coughs

  • Name:

    Benylin Children's Chesty Coughs

  • Company:
    info
  • Active Ingredients:

    Guaifenesin

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/04/18

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Summary of Product Characteristics last updated on medicines.ie: 17/6/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 66 items.Total: Infinity pages

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 17 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 2 May 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd.

 

Updated on 26 April 2018 PIL

Reasons for updating

  • Company name change or merger

Updated on 24 April 2018 SmPC

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

Legal category: Supply through pharmacy only

Updated on 29 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 July 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 14 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 14 July 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SNAS 1203

Section 4.4  - warning added

If cough tends to recur or is accompanied by a fever, rash or persistent headache, a physician should be consulted

Section 4.6 updated as follows:

Section 4.6 updated as follows:

Section 4.6 updated as follows:

This product has been formulated specifically for children, and would therefore not normally be taken during pregnancy and lactation.

 

 Pregnancy

There are no or limited amount of data from the use of guaifenesin in pregnant women.  Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).                    

BENYLIN Children’s Chesty Cough is not recommended during pregnancy and in women of childbearing potential not using contraception. 

 

Breastfeeding

Guaifenesin is excreted in breast milk in small amounts.   There is insufficient information on the effects of Guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from BENYLIN Children's Chesty Coughs therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

 


Section 4.7 - updated as follows:
It is not expected that this product would interfere with the ability to drive or operate machinery


Section 4.8 updated as follows & HPRA details for AE reporting added:

 

Body System (SOC)

Adverse Event preferred term

 

Frequency Category

Immune System Disorders:

Hypersensitivity reactions (Hypersensitivity, pruritus, and urticaria)        

 

Not known

Rash   

Not known

Gastrointestinal Disorders:

 

Abdominal pain upper                                   

Not known

Diarrhoea                                                       

Not known

Nausea                                                           

Not known

Vomiting                                                       

Not known

Section 4.9 updated as follows:

When taken in excess, Guaifenesin may cause renal calculi.

 

Updated on 6 February 2014 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.5:

Added:

A spoon with a 5 ml and 2.5 ml measure is supplied with the pack.

Updated on 4 February 2014 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 3 February 2014 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1

Strawberry 580.193/T

changed to:

Strawberry Flavour

Updated on 22 July 2011 SmPC

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 pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:

Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:

Use only when simple measures have failed to provide adequate relief.

Use for more than 5 consecutive days is not recommended

Section 4.3

CI in children under 6.


Section 4.4

Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours. 

changed to:

Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours. 

 

Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:

Consult a pharmacist or other healthcare professional before use in children under 12 years.

Updated on 21 July 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to dosage and administration

Updated on 28 April 2011 SmPC

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 pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Children aged 6 to 12 years:-  "Use only when simple measures have failed to bring adequate relief.  Use for more than 5 consecutive days is not recommended" has been added.
Section 4.2 Children aged 2 to 5 years:- This paragraph detailing method of administration has been removed.
Section 4.2 Children under 2 years:-  Has been changed to "Children under 6 years".
Section 4.2 Children under 2 years:-  "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 2 years of age, except on the advise of a physician" has been changed to "BENYLIN Children's Chesty Coughs is not recommended for administration to children under 6 years of age".

Section 4.3 Contra-indications:-  "BENYLIN Children's Chesty Coughs is contra-indiciated in children under 6 years" has been added.

Section 4.4 Special Warnings and special Precautions for use:-  "Consult a pharmacist or other healthcare professional before use in children under 6 years" has been changed to "Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years"
 

Updated on 6 December 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Inclusion of child resistant cap.

Updated on 1 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 January 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Inclusion of additional 2 piece child resistant container closure system.

Updated on 2 September 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient

Updated on 2 September 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Renewal Changes made:
 
Section 1 - Change from Benylin Children's Chesty Cough to Benylin Children's Chesty Cough 50mg/5ml Syrup
 
Section 2 - Inclusion of excipient sorbitol liquid
 
Section 6.1 - Includion of E numbers after excipients (where relevant)

Updated on 9 July 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 June 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Added to section 4.4:
 
 

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children under 6 years.

Updated on 19 May 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24

Updated on 13 October 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 21 September 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 10 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only