Label: GUAIFENESIN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 22, 2025

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient (in each extended-release tablet)
    Guaifenesin, USP 600 mg
  • Purpose
    Expectorant
  • Uses
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings
    Do not use - for children under 12 years of age - Ask a doctor before use if you have - persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema - cough ...
  • Directions
    do not crush, chew, or break extended-release tablet - take with a full glass of water - this product can be administered without regard for the timing of meals - adults and children 12 years of age ...
  • Other information
    store between 20-25°C (68-77°F) TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
  • Inactive ingredients
    colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.
  • Questions?
    call toll-free Monday to Friday 8:30 am to 5:00 pm EST at - 1-800-406-7984.
  • SPL UNCLASSIFIED SECTION
    Distributed By: AmerisourceBergen - 1 West First Avenue - Conshohocken, PA 19428 - PRODUCT OF INDIA - CODE No.: PB/DRUGS/1809-0SP - 0425
  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
    NDC 46122-750-51 - Compare to - active ingredient in - Mucinex - ® † GOOD - NEIGHBOR - PHARMACY - ® 12 HOUR - Mucus • ER - Guaifenesin Extended-Release - Tablets, 600 mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information