Drugplain

Mucinex DM 30 mg/1

Guaifenesin and Dextromethorphan Hydrobromide · TABLET, EXTENDED RELEASE · Sportpharm LLC

2 Recalls on Record
Plain English

Mucinex DM is an over-the-counter tablet that combines an expectorant to help thin mucus and make coughs more productive with dextromethorphan, a cough suppressant. It is used to relieve coughs and congestion associated with colds, flu, and other respiratory conditions.

Key Facts

Brand Name
Mucinex DM
Generic Name
Guaifenesin and Dextromethorphan Hydrobromide
NDC Code (Product)
85766-176
Manufacturer
Sportpharm LLC
Strength
30 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA021620
Drug Class
Expectorant [EPC]
Marketing Start
06/26/2012

Recall History

2 Recalls on Record
Class III11/10/2014

Reckitt Benckiser LLC

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective921 reports
dizziness836 reports
diarrhoea625 reports
accidental overdose523 reports
nausea500 reports
overdose380 reports
product use in unapproved indication343 reports
somnolence291 reports
feeling abnormal281 reports
vomiting280 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use

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.

Frequently Asked Questions

What is Mucinex DM used for?

Mucinex DM is an over-the-counter tablet that combines an expectorant to help thin mucus and make coughs more productive with dextromethorphan, a cough suppressant. It is used to relieve coughs and congestion associated with colds, flu, and other respiratory conditions.

Is Mucinex DM a controlled substance?

Mucinex DM is not classified as a controlled substance by the DEA.

What is the generic name for Mucinex DM?

The generic name for Mucinex DM is Guaifenesin and Dextromethorphan Hydrobromide. There are 9 other brand versions of Guaifenesin and Dextromethorphan Hydrobromide.

What is the NDC code for Mucinex DM 30 mg/1?

The NDC (National Drug Code) for Mucinex DM 30 mg/1 is 85766-176, listed by Sportpharm LLC.

Product NDC

85766-176

Package NDC

85766-176-20

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)