Label: GUAIFENESIN tablet, extended release

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

Drug Label Information

Updated May 15, 2026

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  • WARNINGS

    Do not use for children under 12 years of age

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin ER 600mg Tablet

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:87448-1701(NDC:70010-199)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87448-1701-21 in 1 POUCH; Type 0: Not a Combination Product08/19/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342008/19/2022
    Labeler - Northwestern Memorial HealthCare (144944229)
    Registrant - Northwestern Memorial HealthCare (144944229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwestern Memorial HealthCare144944229repack(87448-1701)
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Safety

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