Label: MUCUS RELIEF- guaifenesin 400 mg tablet

  • NDC Code(s): 72090-013-01
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive
  • Warnings

    Do not use: for children under 12 years of age

  • Ask a doctor before use if you have

    • persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough is accompanied by too much phlegm (mucus)
  • Stop use and ask a doctor if

    • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health care 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) immediately.

  • Directions

    • Adults and children 12 years 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 under 12 years:do not use
  • 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
  • Inactive ingredients

    Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Maize Starch, Microcrystalline Cellulose, Povidone K-30, Sodium Lauryl Sulphate

  • Questions or Comments ?

    Call 1-732-698-5070 Monday through Friday 9 am to 5 pm EST 

  • SPL UNCLASSIFIED SECTION

    This product is not manufcatured or distributed by Reckitt Benckiser's , owner of the Registered Trademark MUCINEX®

  • SPL UNCLASSIFIED SECTION

    Distributed by: GenCare Consumer Products, LLC

    40E Cotters Ln Suite A, East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANEL

    NDC 72090-013-01

    PL0142-Mucus Relief Regular Strength 200ct-TCB 08.10.2023_page-0001

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin 400 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-013
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize17mm
    FlavorImprint Code GT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-013-01200 in 1 BOTTLE; Type 0: Not a Combination Product01/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/19/2024
    Labeler - Pioneer Life Sciences, LLC (014092742)
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