Modified-release tablet. Blue/white bi-layered, oval, tablets with "600"on white immediate release layer and "Mucinex"on blue sustained release layer. Blue/white bi-layered, oval, tablets with "1200" on white immediate release layer and "Mucinex"on blue sustained release layer.
Helps loosen phlegm and thin bronchial secretions. Symptomatic relief of deep chesty coughs. Expectorant for productive cough.
For oral use. Adults and children 12 years and over:
Mucinex 600mg tablets
One to Two tablets to be taken with water every 12 hours. Do not exceed four tablets in 24 hours.
Maximum Strength Mucinex 1200mg tablets
One tablet to be taken with water every 12 hours. Do not exceed two tablets in 24 hours.
The tablet should not be chewed because this will affect the modified-release characteristics of the tablet. Children under 12: Do not use. Elderly: no changes to the posology scheme are required.
Hypersensitivity (allergy) to the active substance or to any of the ingredients.
If symptoms persist or no improvements are observed, do not exceed the recommended dose. Seek medical advice. Patients suffering from the following should not take Mucinex except on medical advice:- asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, smoker's cough, porphyria.
As with all medicines, if pregnant or breast feeding, seek medical advice before taking this product. There have been no adequate and well-controlled studies in pregnant women.
Mucinex has no influence on the ability to drive and use machines
Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with some diagnostic measurements (urinary 5-hydroxy- indoleactic acid or vanillylmandelic acid).
Guaifenesin has occasionally been reported to cause gastrointestinal (stomach) discomfort, nausea and vomiting, particularly in high doses. Kidney stones have been reported in patients seeking to abuse the sympathomimetic (decongestant) or opiate component of combination products; which resulted in them taking large doses of Guaifenesin for long periods of time; doses up to 24 g per day have been reported. The development of kidney stones in single active preparations of Guaiphenesin like Mucinex is extremely rare. Guaiphenesin is rapidly metabolised and excreted in the urine.
Overdose with Guaifenesin is unlikely to produce toxic effects since its toxicity is low. Very large doses may cause nausea and vomiting. Guaiphenesin is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.
ATC code: R05 CA03. Guaifenesin is an expectorant which increases the volume of mucus that can be expelled or cleared by mucocilliary action due to reduction in the adhesiveness and viscosity of tenacious sputum.
Guaifenesin is readily absorbed from the gastrointestinal tract after oral administration and rapidly metabolised by oxidation to b-(2-methoxyphenoxy)-lactic acid. Approximately 40% of a dose is excreted as this metabolite in the urine within 3 hours. The half-life in plasma is approximately 1 hour. 600mg modified release Guaifenesin tablet administered every 12 hours has clearly been shown to be equivalent in exposure (as assessed by AUC) and in maximum concentration (as assessed by Cmax) as that produced by 400mg immediate release Guaifenesin given every 4 hours. Pharmacokinetic studies show that a single dose of 1200mg modified release Guaifenesin tablet reaches therapeutic blood levels of 65ng/ml in 8 minutes post dose. Therapeutic blood levels are maintained for at least 16 hours.
No pre-clinical findings of relevance to the prescriber have been reported. Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.
Microcrystalline cellulose Sodium starch glycollate Hypromellose Carbomer Brilliant Blue FCF (E133) Magnesium stearate
Not applicable
3 years.
Do not store above 25degC.
Pack sizes:
600mg tablets:10, 20 tablets
1200mg tablets: 14 tablets (Not Marketed)
Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blister strips, with a foil/paper laminate, enclosed in a cardboard carton.
General Sales: Up to 40 600mg modified release tablets Up to 20 1200mg modified release tablets Pharmacist Only Medicine: 41 - 120 600mg modified release tablets 21 - 60 1200mg modified release tablets
Reckitt Benckiser (New Zealand) Limited, Private Bag 93121 Henderson 0650 Auckland, New Zealand Freephone: 0508 731 234
26 June 2013