GUAIFENESIN 400MG (GUAIFENESIN) TABLET [MEDLINE INDUSTRIES]

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GUAIFENESIN 400MG (GUAIFENESIN) TABLET [MEDLINE INDUSTRIES]
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NDC 53329-987-62
Set ID 6cd11814-c707-1b74-e053-2991aa0a0619
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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 Product05/22/201812/31/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/22/201812/31/2021
    Labeler - Medline Industries, LP (025460908)
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