Label: GUAIFENESIN 400- guaifenesin tablets 400 tablet

  • NDC Code(s): 57631-012-00
  • Packager: InvaTech Pharma Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2025

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  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    cough, cold

  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

    Calcium sennosides 20% IH, Colloidal Silicon Di oxide USP/NF, Croscarmellose sodium USP/NF, Crospovidone [Kollidon] USP/NF, Dicalcium phosphate/ dibasic calcium phosphate [DIREC] USP/NF, Filmcoat AMB-51D0393632-Blue lake IH, Magnesium stearate. USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Sodium lauryl sulfate USP/NF, Stearic acid powder USP/NF, Purified water

    Sennosides Tablets USP, 25 mg Label

  • PRINCIPAL DISPLAY PANEL

    guaifenesin

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 400 
    guaifenesin tablets 400 tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code EB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-012-0028000 in 1 BOX; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/13/2021
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Registrant - Elysium Pharmaceuticals Ltd (915664486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd915664486analysis(57631-012) , manufacture(57631-012)
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