Mucus Relief Dm Tablet
FDA Label NDC 37835-403

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Mucus Relief Dm (NDC 37835-403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 
  • help make coughs more productive

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 a 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 excessive phlegm (mucus)

When Using This Product

do not use more than directed.

Stop Use And Ask A Doctor If

  • symptoms are accompanied by fever, rash, or persistent headache
  • cough persists for more than one week or tends to recur

    • 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 (1-800-222-1222) right away.

Directions

  • take with a full glass of water
  • adults and children 12 years of age and over:take 1 tablet every 4 hours as needed
  • Children under 12 years of age: do not use

Other Information

  • store at 15° - 30°C (59° to 86°F)

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol (PEG 400), povidone (PVP K-30), sodium starch glycolate, stearic acid.

Questions?

call toll-free  1-844-912-4012

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