Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Guaifenesin, Levomenthol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine Check the table below to see how much medicine to take. ■ For oral use only. ■ Do not use more than the stated dose shown.
Children under 12 years
■
This medicine is not recommended for children under 12 years old.
Adults and children aged 12 years and over AGE
DOSE
Adults and children aged Take Two 5 ml spoonfuls 12 years and over four times a day. Do not take more than 4 doses in 24 hours. If symptoms persist, talk to your doctor or pharmacist.
If anyone has too much If anyone has too much contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this pack with you.
If you forget to take the medicine You should only take this medicine as required following the dosage instructions carefully. If you forget to take a dose, take the next dose when needed. Do not take a double dose.
125 ml
3 574661 694139 > LOT EXP
FPO BRAILLE PREVIEW
CHESTY benylin chesty coughs non drowsy
COUGHS
NON-DROWSY Guaifenesin & Levomenthol
c h e s t co n g
t ion
TM
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✓ Deep penetrating relief ✓ Absorbs in 15 minutes
benylin chesty coughs non drowsy
BACK
benylin chesty coughs non drowsy
FRONT
Re d
CHILD
Project Name / Design GB_Benylin Chesty Coughs Non Drowsy 125ml_Carton_Windsor_BV3987
ArtWorks ID
EMEA_2022_00062514_000
Old Component / Item Code
N/A
Languages
English
Job / Version No.
402698605_r1
Product / Eurocode / Mat. ID Code XXXXXX
PANTONE 185 C
PANTONE 7435 C
Black
Varnish
FLEXO
FLEXO
FLEXO
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REPRESENTATION:
CHESTY
Date 31-01-2022
125 ml
Colours represented with a diagonal line have been modified to aid PDF approval.
MANUFACTURING SITE Reference
ETQ014
Security Code / ICFP N/A
Substrate
White
Prefix : LOT EXP
LOT EXP
TECHNICAL DETAILS Component
Label
Plant
Delpharm Orléans
Dimensions
50 x 90 mm
Master Dieline
JJDEL_00060_V1
Date 12-05-2020
Profile
Text Limit
Bleed
Fold/Technical
Perforation
Stamping Area
Coding (Silent Zone)
Print & Varnish Free
Print Free
Varnish Free
Seal Area
Tamper Evident Label Area
Braille Grid
2022-01-24 13:50:27
Gotham-Bold Gotham-Medium GothamNarrow-Bold GothamNarrow-Medium
Smallest Text Size 6.5pt
Ave. Text Size 7.0pt
Largest Text Size 12.1pt
XXXXXXXX
XXXXXX
EXP
New Component / Item Code
Fonts used
CHILD
Project Name / Design GB_Benylin Chesty Coughs Non Drowsy 125ml_Label_ROEP_3513
LOT
Do not store above Not recommended for children FPO 30 ̊C. under 12 years old. Do not use more than 4 doses in 24 Store in the original hours. Do not exceed the stated dose. container. Do not use if As with all similar medicines, if you are bottle seal is broken when pregnant or breast-feeding, consult purchased. Keep out of the COUGHS your doctor or pharmacist before sight and reach of children. NON-DROWSY taking this product. Please consult Marketing Authorisation Guaifenesin & your doctor or pharmacist if holder: Levomenthol symptoms persist. McNeil Products Ltd, High CONTENTS: Each 5 ml of cough Wycombe, HP12 4EG, UK. DOSE: For oral syrup contains: Guaifenesin 100 mg, PL 15513/0056 use only. Adults Levomenthol 1.1 mg. Also contains: Benylin is a registered trade and children aged Liquid glucose, sucrose, ethanol, mark. 12 years and over: sodium, E124, E211. Two 5 ml spoonfuls Please read the outer carton carefully four times a day. before use and retain it for future reference.
Like all medicines, this medicine can cause side-effects, although not everybody gets them. If you experience any of the following stop using the medicine and seek medical help immediately: ■ Allergic reactions including skin rashes (which may be severe and include blistering and peeling of the skin) and itching. Other effects that may occur include: ■ Nausea, vomiting, stomach pain or diarrhoea. Reporting of side-effects If you experience any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed here. You can also report side-effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side-effects, you can help provide more information on the safety of this medicine.
SMALLEST TEXT SIZE
4.00 pt AVE. TEXT SIZE
7 pt LARGEST TEXT SIZE
31.02 pt
Do not store this product above 30 ̊C. ̊ Store in the original container. Do not use if bottle seal is broken when purchased. Keep the product out of the sight and reach of children. Do not use your medicine after the date shown as an expiry date on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Retain carton for full instructions.
1. What the medicine is for
CHESTY COUGHS
NON-DROWSY Guaifenesin & Levomenthol ✓ Deep penetrating relief ✓ Absorbs in 15 minutes
6. Further information: What's in this medicine?
TM
UK Only
c h e s t co n g
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What the medicine looks like Benylin Chesty Coughs Non-Drowsy is a clear red syrup, available in 125 ml, 150 ml and 300 ml glass bottles.
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es
The active ingredients in 5 ml of Benylin Chesty Coughs Non-Drowsy are: 100 mg Guaifenesin and 1.1 mg Levomenthol. Other ingredients are: Sucrose, liquid glucose, ethanol, glycerol, sodium citrate, saccharin sodium, citric acid monohydrate, sodium benzoate (E211), Ponceau 4R (E124), caramel (E150), carbomer, raspberry essence, natural sweetness enhancer and water.
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Benylin Chesty Coughs Non-Drowsy is a medicine which is used to help relieve chesty coughs. It contains Guaifenesin (an expectorant) to help loosen mucus (phlegm) from the lungs and make it easier to cough up, and Levomenthol to help you breathe more easily by easing congestion. The medicine is for use in adults and children aged 12 years and over.
2. Before taking this medicine This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not use this medicine If you have ever had a bad reaction to any of the ingredients. ■ For a child under 12 years of age. ■
If any of these apply to you, get advice from a doctor or pharmacist without using Benylin Chesty Coughs Non-Drowsy.
Talk to your doctor or pharmacist If you suffer from liver or kidney problems. ■ If you have been told by your doctor that you have an intolerance to some sugars. ■ If you have had a cough for a few weeks that may be caused by asthma, or a cough which brings up a lot of mucus (phlegm). ■ If you are taking alcohol. If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist. Marketing Authorisation holder: McNeil Products Ltd, High Wycombe, HP12 4EG, UK. Manufacturer: Delpharm Orléans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France. PL 15513/0056 This carton was revised in January 2024. Recycling information: Carton and leaflet: recycle. Bottle: rinse, cap on, recycle. Benylin is a registered trade mark. McNeil Products Limited 2024 ©
If you are pregnant or breast-feeding ■
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding.
Some of the ingredients can cause problems Contains 3.5 g of glucose and 1 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. ■ This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. ■ This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions. ■ This medicine contains 16.43 mg sodium (main component of cooking/ table salt) in each 5 ml. This is equivalent to 0.82% of the recommended maximum daily dietary intake of sodium for an adult. ■ This medicine contains 10 mg sodium benzoate (E211) in each 5 ml. ■
The active substance in Benylin Chesty Coughs (Non-Drowsy) is guaifenesin, levomenthol.
Medicines with the same active substance, strength and form include: Benylin Mucus Cough. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Benylin Chesty Coughs (Non-Drowsy), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic relief of
cough.
Adults and children aged 12 years and over:
Oral. Two 5 ml spoonfuls four times a day.
Children under 12 years:
This product is contraindicated in children under the age of 12 years (see section 4.3).
The Elderly:
As for adults.
Hepatic/renal dysfunction
Experience with the use of this product suggests that normal adult dosage is appropriate for mild to moderate dysfunction. Caution should be exercised in severe hepatic and severe renal impairment. [See Pharmacokinetics].
Do not exceed the stated dose.
Keep out of the sight and reach of children.
This product is contraindicated in individuals with known hypersensitivity to the product, or any of its components.
Not to be used in children under the age of 12 years.
This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.
Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment, [See Pharmacokinetics].
Contains 3.5 g of glucose and 1 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicinal product contains 16.43 mg sodium per 5 ml, equivalent to 0.82% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicine contains 10 mg sodium benzoate (E 211) in each 5 ml.
This product contains Ponceau 4R (E 124) red colouring which may cause allergic reactions.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
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). Insufficient information is available on the effects of administration of this product during human pregnancy. This product 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 this product, 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.
This product has no or negligible influence on the ability to drive or operate machinery.
The safety of guaifenesin/menthol is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience are included.
The frequencies are provided according to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports
Not known (cannot be estimated from the available data)
ADRs are presented for frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies if available or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'
Adverse Drug Reactions identified During Clinical trials, Epidemiology studies and Post-Marketing Experience with Guaifenesin. Frequency Category Estimated from Clinical Trials or Epidemiology Studies.
Body system
Incidence
Reported adverse event
Immune System Disorders
Not known
Hypersensitivity reactions (hypersensitivity, pruritus and urticaria)
Rash
Gastrointestinal Disorders
Not known
Abdominal pain upper
Diarrhoea
Nausea
Vomiting
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms and signs
The effects of acute toxicity from guaifenesin may include gastro-intestinal discomfort, nausea and drowsiness.
When taken in excess, guaifenesin may cause renal calculi.
Treatment
Treatment should be symptomatic and supportive.
Ask anything about Benylin Chesty Coughs (Non-Drowsy). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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