Mucus Relief Dm Tablet
FDA Label NDC 84324-035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Mucus Relief Dm (NDC 84324-035). 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:, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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 400mg

Purpose

Dextromethorphan HBr 20 mg ......................................... Cough suppressant
Guaifenesin 400mg ........................................................................ Expectorant

Uses:

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves
   o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
   o the intensity of coughing
   o the impulse to cough to help you get to sleep

Warnings:

Do Not Use

  • for children under 12 year 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 sign of serious illness.

Directions:

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: Do not use

Other Information:

Store between 20°C-25°C (68°F-77°F).

  • Keep in a dry place and do not expose to heat 
  • do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients:

microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow

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