Label: MUCUS RELIEF IMMEDIATE RELEASE- guaifenesin 400mg tablet

  • NDC Code(s): 76162-004-01, 76162-004-81
  • Packager: TopCo Associates, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 21, 2021

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  • Active ingredient(s)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Use(s)

    helps loosen phlegm (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 recommended 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.

    Pregnancy/Breastfeeding

    ask a healthcare professional before use.

    Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children12 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 under12 years of age:  do not use

  • Other information

    • do not use if imprinted safety seal under cap is broken or missing
  • Storage

    •  store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)
    •  keep in a dry place and do not expose to heat
  • Inactive ingredients

    Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

  • Questions

    Call 1-888-423-0139

  • Principal Display Panel

    Mucus Relief

    Mucus Relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF  IMMEDIATE RELEASE
    guaifenesin 400mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-004-812 in 1 CARTON12/23/201401/31/2022
    1200 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76162-004-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/23/2014
    Labeler - TopCo Associates, LLC (006935977)
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