Mucus Relief Tablet
FDA Label NDC 84324-009

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 (NDC 84324-009). 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, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, inactive ingredients, 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)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive

Ask A Doctor Before Use If You Have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough is accompanied by too much phlegm (mucus)

Stop Use And Ask A Doctor If

  • cough lasts for more than 7 days, come back, or occur with fever, rash, or persistent headache. These could be signs of a serious illness.

Directions

  • Adults and children 12 years and older:take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years:do not use

Other Information

  • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • Keep in a dry place and do not expose to heat
  • Read all product information before using

Inactive Ingredients

Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid Powder, Sodium Starch Glycolate

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