Label: TOPCARE MUCUS D- guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 30, 2023

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  • Active ingredients (in each extended-release bi-layer tablet)

    Guaifenesin 600 mg

    Pseudoephedrine HCl 60 mg

  • Purposes

    Expectorant

    Nasal Decongestant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
    •
    temporarily relieves sinus congestion and pressure
  • Warnings

    Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI , ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    •
    cough accompanied by too much phlegm (mucus)

    When using this product

    •
    do not use more than directed

    Stop use and ask a doctor if

    •
    you get nervous, dizzy, or sleepless
    •
    symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
    •
    adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    do not use if printed blister unit is broken or torn
    •
    store between 20-25˚C (68-77˚F)
  • Inactive ingredients

    carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 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® D ACTIVE INGREDIENTS

    Mucus-D

    GUAIFENESIN 600 mg

    PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg

    EXTENDED-RELEASE BI-LAYER TABLETS

    EXPECTORANT/NASAL DECONGESTANT

    12 HOUR

    • Clears Nasal/Sinus Congestion

    • Thins And Loosens Mucus

    • Immediate and Extended Release

    18 EXTENDED-RELEASE BI-LAYER TABLETS

    actual size

    mucus-d-image
  • INGREDIENTS AND APPEARANCE
    TOPCARE MUCUS D 
    guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code L6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-801-8918 in 1 CARTON08/16/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21440708/16/2023
    Labeler - Topco Associates LLC (006935977)
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