Label: MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

  • NDC Code(s): 41250-934-14, 41250-934-28, 41250-934-42
  • Packager: MEIJER, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 11, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients (in each extended-release tablet)

    Dextromethorphan HBr 60 mg

    Guaifenesin 1200 mg

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  • Purpose

    Cough Suppressant

    Expectorant

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  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough 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
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  • Warnings

    Do not use

    • for children under12 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 condition.

    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).

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  • Directions

    • do not crush, chew, or break tablet
    • take with a full glass of water 
    • this product can be administered without regards for timing of meals
    • adults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours
    • children under 12 years of age: do not use 
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  • Other information

    store between 20º to 25ºC (68º to 77ºF)

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  • Inactive ingredients

    carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    *Compare to the active ingredients in Maximum Strength Mucinex® DM

    MAXIMUM STRENGTH

    Mucus Relief DM

    Guaifenesin | 1200 mg

    Expectorant

    Dextromethorphan HBr | 60 mg

    Cough Suppressant

    12 HOUR RELIEF

    Controls Cough, Thins & Loosens Mucus

    Extended Release Tablets

    *This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex® DM.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DIST. BY MEIJER

    DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

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  • Package Label

    Dextromethorphan HBr 60 mg, Guaifenesin 1200 mg

    MEIJER Maximum Strength Mucus Relief DM

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM EXTENDED RELEASE CAPLETS 
    guaifenesin, dextromethorphan hbr tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-934
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 22mm
    Flavor Imprint Code AN039
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-934-42 42 in 1 CARTON 11/05/2018
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:41250-934-28 28 in 1 CARTON 11/05/2018
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:41250-934-14 14 in 1 CARTON 11/05/2018
    3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA209692 11/05/2018
    Labeler - MEIJER, INC. (006959555)
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