Label: MUCUS RELIEF- guaifenesin tablet

  • NDC Code(s): 68210-4102-1, 68210-4102-2, 68210-4102-5
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Drug Facts 

  • Active ingredient (in each caplet) 

    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

    Warnings

    Do not use

    ■ for children under 12 years of age 

  • 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 too much phlegm (mucus) 

  • 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. 

  • 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 right away. (1-800-222-1222)

  • Directions

    ■ do not crush, chew, or break caplet ■ take with a full glass of water
    ■ adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms
    persist. Do not exceed 6 caplets 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

  • PDP

    Mucus Relief
    Guaifenesin 400mg

    50 Tablets

    image description

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4102
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code EB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4102-250 in 1 PACKAGE; Type 0: Not a Combination Product07/02/2020
    2NDC:68210-4102-1200 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    3NDC:68210-4102-5150 in 1 BOTTLE; Type 0: Not a Combination Product10/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/02/2020
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
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