Mucus Relief Tablet
FDA Label NDC 66424-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Mucus Relief (NDC 66424-001). 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 caplet), purpose, uses, warnings, otc - keep out of reach of children, 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 Caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Warnings

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)

    • Stop use and ask a doctor if

    • cough lasts more than 7 days or comes back
    • cough 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.

Directions

  • take with full glass of water
  • not intended for use in children under 12 years of age
    • Adults and children 12 years
    of age and over
    • take 1 caplet, every 4 hours, while
      symptoms persist 
    • do not exceed 6 doses in 24 hours
    Children under 12 years of agedo not use

* Please review the disclaimer below.