Label: TOPCARE MUCUS ER- guaifenesin tablet, multilayer, extended release

  • NDC Code(s): 76162-123-58, 76162-123-60
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2024

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  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 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

    •
    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.

    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
    •
    this product can be administered without regard for the timing of meals
    •
    adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

    microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    TopCare® health

    COMPARE TO MUCINEX® ACTIVE INGREDIENT

    Mucus ER

    GUAIFENESIN

    EXTENDED-RELEASE TABLETS, 600 mg

    EXPECTORANT

    12 HOUR

    • Relieves Chest Congestion

    • Thins and Loosens Mucus

    • Immediate and Extended Release

    40 EXTENDED-RELEASE TABLETS

    actual size

    Mucus ER image
  • INGREDIENTS AND APPEARANCE
    TOPCARE MUCUS ER 
    guaifenesin tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code L2X2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-123-581 in 1 CARTON09/29/2022
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76162-123-601 in 1 CARTON11/04/2024
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07891209/29/2022
    Labeler - Topco Associates LLC (006935977)
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