Label: GUAIFENESIN tablet

  • NDC Code(s): 71679-309-00, 71679-309-02
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2025

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

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

    ​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 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

    When using this product

    • Do not exceed recommended dosage.
    • Do not consume alcohol, benzodiazepines or opioids.
  • STOP USE

    Stop use and ask a doctor if

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    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 use.
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • INACTIVE INGREDIENT

    Inactive ingredients
    Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.

  • QUESTIONS

    Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    71679-309-02-MucusRelief-Guai 400mg-200s-FINALLabel

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-309
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code G400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-309-0038500 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2024
    2NDC:71679-309-02200 in 1 BOTTLE; Type 0: Not a Combination Product02/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/07/2024
    Labeler - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd.915664486manufacture(71679-309) , analysis(71679-309)
    Establishment
    NameAddressID/FEIBusiness Operations
    HHH Pharmaceuticals144848997pack(71679-309)
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