Mucus Relief Tablet
FDA Label NDC 72090-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Mucus Relief (NDC 72090-013). 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, stop use and ask a doctor if, directions, other information, 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

Warnings

Do not use: for children under 12 years of age

Ask A Doctor Before Use If You Have

  • persistent 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, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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, Croscarmellose Sodium, Magnesium Stearate, Maize Starch, Microcrystalline Cellulose, Povidone K-30, Sodium Lauryl Sulphate

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