Benylin Phlegm Cough Syrup

  • Name:

    Benylin Phlegm Cough Syrup

  • Company:
    info
  • Active Ingredients:

    Guaifenesin, Levomenthol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/06/18

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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

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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
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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
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Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
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1 - 0 of 65 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 general sale

Updated on 12 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Supply through general sale

Updated on 12 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 20 June 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Underlined text has been added, struck through text has been removed:

1.         Name of the Medicinal Product

 

            Benylin Phlegm Cough Syrup

            Guaifenesin 100mg/5ml

 

            Levomenthol 1.1mg/5ml Syrup

6.5       Nature and contents of container

Amber glass bottles (pharmacopoeial grade III) with an aluminium ROPP cap with melinex-faced pulpboard wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a PE-Alu-PET or polyethylene/ expanded polyethylene laminated wad or with a plastic HDPE cap fitted with a PE-Alu-PET wad..
Pack sizes: 30 ml, 125 ml, 150ml or 300 ml.

Not all pack sizes may be marketed.

 

10.       Date of revision

June 2016

 

 

Updated on 20 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 16 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on alternative format leaflets

Updated on 29 July 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 11 March 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 4.6 updated as follows:

Pregnancy

There are no or limited amounts of data from the use of Guaifenesin in pregnant women.  Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Non-Drowsy Chesty Coughs 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 Non-Drowsy 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 4.8 updated as follows & HPRA details for AE reporting added:

Body System (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Immune system Disorders

Not known

Hypersensitivity (including Pruritus and Urticaria)

 

Gastrointestinal Disorders

Not known
Not known

Not known

Not known

Not known

Abdominal discomfort
Abdominal pain upper

Diarrhoea

Nausea

Vomiting

 

Skin and Subcutaneous Tissue Disorders

Not known

Rash



Section 4.9 updated as follows:

Symptoms and signs

 

Guaifenesin

The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and somnolence. When taken in excess, Guaifenesin may cause renal calculi.

 

Menthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia

Updated on 9 March 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 24 August 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 August 2012 PIL

Reasons for updating

  • New PIL for new product