MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]

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MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]
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NDC 0363-6812-30, 0363-6812-55, 0363-6812-66
Set ID ba200f15-56dd-4b4d-9f3f-1340f3cb73a5
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA207602
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  • 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

    Compare to Maximum Strength Mucinex® DM active ingredients

    12 HOUR

    Mucus Relief DM

    GUAIFENESIN 1200 mg / DEXTROMETHORPHAN HYDROBROMIDE 60 mg

    EXTENDED-RELEASE TABLETS

    EXPECTORANT / COUGH SUPPRESSANT

    MAXIMUM STRENGTH

    12 HOUR

    Controls cough

    Thins & loosens mucus

    14 EXTENDED-RELEASE TABLETS

    ACTUAL SIZE

    mucus relief DM image
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hydrobromide, guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6812
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (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:0363-6812-661 in 1 CARTON01/07/2019
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-6812-301 in 1 CARTON01/07/2019
    228 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-6812-551 in 1 CARTON12/21/2018
    342 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20760212/21/2018
    Labeler - Walgreen Company (008965063)
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