Label: MUCUS RELIEF- guaifenesin 400 mg tablet

  • NDC Code(s): 71679-119-02, 71679-119-60
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2025

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  • Active ingredient (in each caplet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • Temporary symptomatic relief from congested chests and cough.
  • Warnings

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

    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 consume alcohol, benzodiazepines or opioids.

    Stop use and ask a doctor if

    cough lasts for more than 7 days please consult your physician or healthcare provider.

    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 (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years of age and over: take 1 caplet a day.
    • Children under 12 years:Do not use.
    • Do not exceed 4 doses in 24 hours.
  • Other information

    • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
    • Keep in a dry place and do not expose to heat.
    • Read all product information before using.
    • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

  • Principal Display Panel-60 count

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin 400 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-119-6060 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    2NDC:71679-119-02200 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/18/2025
    Labeler - Health Pharma USA LLC (080804485)
    Registrant - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(71679-119)
    Establishment
    NameAddressID/FEIBusiness Operations
    HHH PHARMA USA LLC062788820pack(71679-119)
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