Label: GUAIFENESIN 400MG- guaifenesin tablet

  • 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 January 22, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient (in each immediate-release tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

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

    When using this product

    • do not exceed recommend dosage
    • do not use for more than 7 days

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a healthcare 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

    • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
    • Children under 12 years of age: do not use
  • Other information

    • store at 25 degrees Celsius (77 degrees Fahrenheit) excursions permitted between 15 degrees to 30 degrees Celsius (fifty nine degrees to eighty six degrees Fahrenheit)
    • keep in a dry place and do not expose to excessive heat
  • Inactive ingredients

    collodial silicon dioxide, magnesium stearate, maltodextrin, microcrystallline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call toll free 1-800-MEDLINE (633-5463)

    Monday-Friday 9AM-5PM CST

  • Package Label

    53329-987-62

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 400MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-987
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL;272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-987-62100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/22/2018
    Labeler - Medline Industries (025460908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs037052099manufacture(53329-987) , pack(53329-987)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medline Industries079800021repack(53329-987)