Label: MUCUS RELIEF- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 15, 2019

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  • ACTIVE INGREDIENT

    Each immediate release tablet contains: Guaifenesin 400 mg

  • INACTIVE INGREDIENT

    Silicon Dioxide, Magnesium Stearate, Maltodextrin, Cellulose, Microcrystalline, Povidone, Sodium Starch Glycolate, Stearic Acid

  • PURPOSE

    PURPOSE: EXPECTORANT

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus) and thin

    bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age 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 of age do not us

  • 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)

  • 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

  • PRINCIPAL DISPLAY PANEL

    30CT

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-272
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-272-0330 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/03/2019
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(41226-272)
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