Mucinex DM
Mucinex DM is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN manufactured by Navajo Manufacturing Company Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230316.
Generic: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Manufacturer: Navajo Manufacturing Company Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 67751-171
Application: NDA021620
Effective: 20230316
Active Ingredients: Active ingredients (in each extended-release bi-layer tablet) Dextromethorphan HBr 30 mg Guaifenesin 600 mg Purposes Cough suppressant Expectorant
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Dosage & Administration
Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use
Contraindications
Not available.
Warnings
Warnings Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Not available.
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