Drugplain

leader tussin dm 20 mg/20mL

dextromethorphan hydrobromide, guaifenesin · SOLUTION · Cardinal Health 110, LLC. dba Leader

No Recall History
Plain English

Leader Tussin DM is an over-the-counter cough medicine that contains dextromethorphan (a cough suppressant) and guaifenesin (an expectorant) to help relieve cough and loosen mucus. This oral solution is taken by mouth and is commonly used to manage cough and congestion associated with colds and upper respiratory infections.

Key Facts

Brand Name
leader tussin dm
Generic Name
dextromethorphan hydrobromide, guaifenesin
NDC Code (Product)
70000-0596
Manufacturer
Cardinal Health 110, LLC. dba Leader
Strength
20 mg/20mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
11/24/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

blister1 reports
clonus1 reports
dermatitis1 reports
diarrhoea1 reports
drug abuse1 reports
erythema1 reports
fixed eruption1 reports
hepatic function abnormal1 reports
hyperchloraemia1 reports
hypersensitivity1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage & Administration

Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL 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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Frequently Asked Questions

What is leader tussin dm used for?

Leader Tussin DM is an over-the-counter cough medicine that contains dextromethorphan (a cough suppressant) and guaifenesin (an expectorant) to help relieve cough and loosen mucus. This oral solution is taken by mouth and is commonly used to manage cough and congestion associated with colds and upper respiratory infections.

Is leader tussin dm a controlled substance?

leader tussin dm is not classified as a controlled substance by the DEA.

What is the generic name for leader tussin dm?

The generic name for leader tussin dm is dextromethorphan hydrobromide, guaifenesin. There are 12 other brand versions of dextromethorphan hydrobromide, guaifenesin.

What is the NDC code for leader tussin dm 20 mg/20mL?

The NDC (National Drug Code) for leader tussin dm 20 mg/20mL is 70000-0596, listed by Cardinal Health 110, LLC. dba Leader.

Product NDC

70000-0596

Package NDC

70000-0596-1

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)