Label: GUAIFENESIN EXTENDED-RELEASE- guaifenesin tablet, multilayer, extended release

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

Drug Label Information

Updated May 27, 2025

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  • SPL UNCLASSIFIED SECTION
    Tablets, 600 mg - For Hospital Use Only - LI1730 Rev. 10/24
  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient (in each extended-release tablet)
    Guaifenesin 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
    Use as directed per healthcare professional. do not crush, chew, or break tablet - take with a full glass of water - this product can be administered without regard for the timing of meals - adults and ...
  • Other information
    store at 20-25°C (68-77°F)
  • Inactive ingredients
    Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
  • Questions or comments?
    1-800-397-9228
  • SPL UNCLASSIFIED SECTION
    Gluten Free
  • How Supplied
    NDC 68094-048-61 - Unit Dose Packages of 100 Tablets (10×10) per Carton
  • SPL UNCLASSIFIED SECTION
    Packaged by: Precision Dose, Inc. South Beloit, IL 61080 - For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com - LI1730 Rev. 10/24
  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
    PrecisionDose™ NDC 68094-048-61 - Unit Dose - guaiFENesin - Extended-Release - Tablets, 600 mg - 100 Tablets - (10 x 10) (in each extended-release tablet) Guaifenesin 600 mg....Expectorant. Directions: do not ...
  • INGREDIENTS AND APPEARANCE
    Product Information