Label: MUCUS RELIEF- guaifenesin 400 mg tablet

  • NDC Code(s): 69517-119-02, 69517-119-05, 69517-119-10, 69517-119-12, view more
    69517-119-16, 69517-119-25, 69517-119-50
  • Packager: HealthLife of USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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

View All Sections
  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • 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.

    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:

    • adults and children 12 years of age and over: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:do not use
  • Other information

    • each tablet contains: sodium 1.24 mg VERY LOW SODIUM
    • 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
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

  • Questions or Comments

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN Guai-Aid® 400*

    Guaifenesin 400 mg

    Expectorant

    * This product is not manufactured or distributed by Health Products Express, Inc., owner of the registered trademark Guai-Aid® 400.

    Mucus relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin 400 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-119
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code EB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-119-2525 in 1 CARTON04/13/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69517-119-5050 in 1 CARTON04/13/2016
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:69517-119-022 in 1 POUCH04/13/2016
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:69517-119-101000 in 1 BOTTLE04/13/2016
    4NDC:69517-119-05500 in 1 BOTTLE
    4NDC:69517-119-1212 in 1 BOTTLE
    41 in 1 CARTON; Type 0: Not a Combination Product
    5NDC:69517-119-161 in 1 CARTON06/05/2017
    516 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/13/2016
    Labeler - HealthLife of USA LLC (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(69517-119)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!