Label: MUCUS RELIEF- guaifenesin 400 mg tablet

  • NDC Code(s): 71309-008-02, 71309-008-03, 71309-008-05
  • Packager: Safrel Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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  • 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 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

  • Principal Display Panel

    200 ct

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin 400 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-008
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-008-02200 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:71309-008-03300 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2016
    3NDC:71309-008-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/13/2016
    Labeler - Safrel Pharmaceuticals, LLC (080566287)
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