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LEMSIP COUGH FOR CHESTY COUGH 50MG/5ML ORAL SOLUTION
Active substance(s): GUAIPHENESIN
NAME OF THE MEDICINAL PRODUCT
Lemsip Cough for Chesty Cough 50mg/5ml Oral Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sucrose: 3.965 g per 5ml dose
Sodium: 3.66 mg (0.16mmol) per 5ml dose
For full list of excipients, see section 6.1
Symptomatic relief of deep chesty coughs and to soothe the throat.
Posology and method of administration
For oral administration.
Under 12 years: On medical advice only
To be taken three or four times daily.
Adults and children 12 years and over: two to four 5ml spoonfuls.
PETE plastic bottle
Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml);
15 ml (one 10 ml measure in cup followed by a 5 ml measure); 20 ml (10 ml
taken twice). Rinse the measure cup after use.
Hypersensitivity to guaifenesin or to any of the excipients.
Special warnings and precautions for use
This medicine contains 0.16 mmol (or 3.66 mg) sodium per 5 ml dose. To be
taken into consideration by patients on a controlled sodium diet.
Contains 3.965 g of sucrose per 5 ml dose. This should be taken into account
in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
Interaction with other medicinal products and other forms of interaction
If urine is collected within 24 hours of a dose of the medicinal product, a metabolite
of guaifenesin may cause a colour interference with laboratory determinations of
urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Guaifenesin may increase the rate of absorption of paracetamol.
Pregnancy and lactation
Guaifenesin has been linked with an increased risk of neural tube defects in a
small number of women with febrile illness in the first trimester of pregnancy.
The product should be used in pregnancy only if the benefits outweigh this
risk. There is no information on use in lactation.
Effects on ability to drive and use machines
Guaifenesin has occasionally been reported to cause gastro-intestinal
discomfort, nausea and vomiting, particularly in very high doses. Also,
hypersensitivity reactions may occur.
Very large doses may cause nausea and vomiting. The drug is, however,
rapidly metabolised and excreted in the urine. Patients should be kept under
observation and treated symptomatically.
Pharmacotherapeutic group: Expectorants
Guaifenesin is reported to reduce the viscosity of tenacious sputum and is used as an
The active ingredient is not known to cause sedation.
Guaiphenesin is absorbed from the gastrointestinal tract. It is metabolised and
excreted in the urine.
Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
List of excipients
Citric acid anhydrous granular,
Lemon oil terpeneless,
Glass bottle - Three years.
PETE bottle - Two years.
Special precautions for storage
Nature and contents of container
Amber glass bottles with a polypropylene cap with a child resistant closure
with a polyethylene tamper-evident band with expanded polyethylene wad
(100ml, 150 ml, 200ml and 300 ml).
Transparent blue plastic PETE bottle (180 ml).
Translucent yellow graduated polypropylene measuring cup.
Pack size: 100 ml, 150 ml, 180ml, 200 ml and 300 ml.
Special precautions for disposal
To be taken orally at the recommended dose.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
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