Label: GUAIFENESIN 400MG- guaifenesin tablet

  • NDC Code(s): 10135-682-30, 10135-682-60
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 3, 2022

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  • SPL UNCLASSIFIED SECTION

    GUAIFENESIN 400MG TABLETS

    Marlex Pharmaceuticals, Inc.

    ----------

    Drug Fact

  • Active ingredient (in each tablet)

    Guaifenesin 400mg

  • Purpose

    Expectorant

    Guaifenesin 400 mg Tablets

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

  • Warnings

    Ask a doctor before use if you have

    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • Cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

     

    If pregnant or breast- feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Do not take more than 6 doses in any 24-hour period.
    • This product is not intended for use in children under 12 years of age
    • Adults & children 12 years and over: 1 to 2 tablets every 4 hours
    • Children under 12 years: do not use
  • Other Information:

    • Store at 15°C-30°C (59°F-86°F)
  • Inactive Ingredients:

    Colloidal silicon dioxide, FD&C RED #40(AI-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

    Manufactured for & Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev: 02/19TCL

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0682-30
    Guaifenesin
    400 mg
    30 CAPLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0682-30 Guaifenesin 400 mg 30 CAPLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0682-30 Guaifenesin 400 mg 30 CAPLETS

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0682-60
    Guaifenesin
    400 mg
    60 CAPLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0682-60 Guaifenesin 400 mg 60 CAPLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0682-60 Guaifenesin 400 mg 60 CAPLETS

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 400MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-682
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size10mm
    FlavorImprint Code G400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-682-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    2NDC:10135-682-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2019
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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