MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [RUGBY LABORATORIES, INC.]

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MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [RUGBY LABORATORIES, INC.]
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NDC 0536-1161-34
Set ID 69cd399a-0103-4543-bb06-c7cccffe9cc4
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA209692
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  • Active ingredients (in each extended-release tablet)

    Dextromethorphan HBr 30 mg

    Guaifenesin 600 mg

  • Purpose

    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 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).

  • 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 
  • Other information

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

  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredients in Mucinex® DM*

    Mucus Relief DM ER

    Guaifenesin 600 mg

    Expectorant HBr 30 mg

    Dextromethorphan HBr 30 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 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.

    Distributed by:

    Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

  • Package Label

    Dextromethorphan HBr 30 mg, Guaifenesin 600 mg

    RUGBY Mucus Relief DM ER

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM EXTENDED RELEASE CAPLETS 
    guaifenesin, dextromethorphan hbr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorYELLOWScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code AN038
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1161-3420 in 1 CARTON12/13/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0536-1161-3740 in 1 CARTON12/13/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20969212/13/2018
    Labeler - Rugby Laboratories, Inc. (079246066)
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