Drugplain

Topcare Mucus DM 60 mg/1

dextromethorphan HBr, guaifenesin · TABLET, EXTENDED RELEASE · Topco Associates LLC

No Recall History
Plain English

Topcare Mucus DM is an over-the-counter tablet that combines dextromethorphan (a cough suppressant) and guaifenesin (an expectorant) to help relieve cough and make mucus easier to clear from your airways. This extended-release formulation is taken by mouth to provide prolonged symptom relief during cold or flu.

Key Facts

Brand Name
Topcare Mucus DM
Generic Name
dextromethorphan HBr, guaifenesin
NDC Code (Product)
36800-592
Manufacturer
Topco Associates LLC
Strength
60 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA207602
Drug Class
Expectorant [EPC]
Marketing Start
09/06/2018

Recall History

No Recall History

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 (1-800-222-1222).

Frequently Asked Questions

What is Topcare Mucus DM used for?

Topcare Mucus DM is an over-the-counter tablet that combines dextromethorphan (a cough suppressant) and guaifenesin (an expectorant) to help relieve cough and make mucus easier to clear from your airways. This extended-release formulation is taken by mouth to provide prolonged symptom relief during cold or flu.

Is Topcare Mucus DM a controlled substance?

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

What is the generic name for Topcare Mucus DM?

The generic name for Topcare Mucus DM is dextromethorphan HBr, guaifenesin. There are 12 other brand versions of dextromethorphan HBr, guaifenesin.

What is the NDC code for Topcare Mucus DM 60 mg/1?

The NDC (National Drug Code) for Topcare Mucus DM 60 mg/1 is 36800-592, listed by Topco Associates LLC.

Product NDC

36800-592

Package NDC

36800-592-30

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)