COUGH AND CHEST CONGESTION DM 20 mg/20mL

dextromethorphan hydrobromide, guaifenesin · SOLUTION · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

1 Recall on Record

Plain English

This oral solution contains dextromethorphan, a cough suppressant, and guaifenesin, an expectorant that helps thin mucus to make it easier to cough up. It is used to relieve cough and chest congestion caused by colds or other respiratory conditions.

Key Facts

Brand Name: COUGH AND CHEST CONGESTION DM
Generic Name: dextromethorphan hydrobromide, guaifenesin
NDC Code (Product): 51316-473
Manufacturer: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength: 20 mg/20mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 02/16/2026

Recall History

1 Recall on Record

Class II06/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective30 reports

diarrhoea14 reports

dizziness14 reports

headache11 reports

cough10 reports

insomnia10 reports

nausea8 reports

dyspnoea7 reports

feeling abnormal7 reports

rash7 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 take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Warnings

Warnings Do not use 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 that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. 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 COUGH AND CHEST CONGESTION DM used for?

Is COUGH AND CHEST CONGESTION DM a controlled substance?

COUGH AND CHEST CONGESTION DM is not classified as a controlled substance by the DEA.

What is the generic name for COUGH AND CHEST CONGESTION DM?

The generic name for COUGH AND CHEST CONGESTION DM is dextromethorphan hydrobromide, guaifenesin. There are 12 other brand versions of dextromethorphan hydrobromide, guaifenesin.

What is the NDC code for COUGH AND CHEST CONGESTION DM 20 mg/20mL?

The NDC (National Drug Code) for COUGH AND CHEST CONGESTION DM 20 mg/20mL is 51316-473, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Product NDC

51316-473

Package NDC

51316-473-34

Other Dextromethorphan Brands

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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)