Label: MUCUS RELIEF- guaifenesin tablet

  • NDC Code(s): 68210-4173-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • Drug Facts

  • 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 make coughs more productive

  • Warnings

    Do not use for children under 12 years of age

  • Ask a doctor before use if you have

    • with persistent or chronic cough such as occurs with smoking,
    asthma, chronic bronchitis, or emphysema • cough accompanied by

  • Stop use and ask a doctor

    if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

  • 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. (1-800-222-1222)

  • Directions

    • do not crush, chew, or break tablet • take with a full glass of water • 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 tablets in 24 hours. • children under 12 years of age: do not use

  • Other information

    • store between 20-25°C (68-77°F)

  • Inactive ingredients

    Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Pouch

    Mucus Relief pouch

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4173
    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)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PYRROLIDINE (UNII: LJU5627FYV)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code EB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4173-330 in 1 POUCH; Type 0: Not a Combination Product11/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/19/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)