Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 51660-566-21, 51660-566-41, 51660-567-54, 51660-567-58, view more
  • Packager: Ohm Laboratories, Inc.
  • 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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  • Active ingredient
    (in each extended-release tablet) Guaifenesin, USP
  • Purpose
    Expectorant
  • Keep Out of Reach of Children
    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
  • Uses
    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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 over 12 years of ...
  • 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
    Keep the carton. It contains important information. See end panel for expiration date. †OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their ...
  • Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg
    spl-guaifenesin-ohm
  • Principal Display Panel - Guaifenesin ER Tablets, 1200 mg
    spl-guaifenesin-ohm2
  • INGREDIENTS AND APPEARANCE
    Product Information