Label: MUCOSA- guaifenesin tablet

  • NDC Code(s): 49483-272-00, 49483-272-06, 49483-272-20
  • Packager: TIME CAP LABORATORIES,INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each immediate-release tablet)

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
  • WARNINGS

    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 healthcare professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • 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 use
  • STORAGE AND HANDLING

    Other information
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • keep in a dry place and do not expose to excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • QUESTIONS

    Questions or comments?

    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    272R-Timely-200s-labelimage description60lable

  • INGREDIENTS AND APPEARANCE
    MUCOSA 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-272
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-272-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2012
    2NDC:49483-272-00100000 in 1 CARTON; Type 0: Not a Combination Product04/16/2012
    3NDC:49483-272-20200 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/16/2012
    Labeler - TIME CAP LABORATORIES,INC (037052099)
    Registrant - TIME CAP LABORATORIES,INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES,INC037052099manufacture(49483-272)
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