GOOD SENSE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [L PERRIGO COMPANY]

GOOD SENSE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [L PERRIGO COMPANY]
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NDC 0113-0812-66
Set ID 654dc991-1984-43cc-a00e-0c85d910b323
Category HUMAN OTC DRUG LABEL
Packager L Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA207602
  • Active ingredients (in each extended-release tablet)

    Dextromethorphan HBr 60 mg

    Guaifenesin 1200 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    temporarily relieves:
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    the intensity of coughing
    the impulse to cough to help you get to sleep
  • Warnings

    Do not use

    for children under 12 years of age
    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

    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

    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 timing of meals
    adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years of age: do not use
  • Other information

    each tablet contains: magnesium 25 mg
    do not use if printed foil under cap is broken or missing
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    12 Hour

    Maximum Strength

    Mucus•DM

    Guaifenesin and Dextromethorphan

    Hydrobromide Extended-Release Tablets, 1200 mg/60 mg

    Actual Size

    Expectorant/Cough Suppressant

    Controls Cough

    Thins and Loosens Mucus

    Compare to active ingredients of Maximum Strength Mucinex® DM

    100% SATISFACTION GUARANTEED

    14 Extended-Release Tablets

    mucus-DM-image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE MUCUS DM 
    dextromethorphan hbr, guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOW (light) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code L812
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0812-661 in 1 CARTON06/21/2018
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0113-0812-037 in 1 CARTON09/09/2021
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20760206/21/2018
    Labeler - L Perrigo Company (006013346)

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