Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

  • NDC Code(s): 41415-998-20
  • Packager: PUBLIX SUPER MARKETS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 24, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purposes
    Dextromethorphan HBr 30 mgCough suppressant
    Guaifenesin 600 mgExpectorant
  • 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 extended-release 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • Store between 68-77°F (20-25°C)
  • Inactive ingredients

    carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
    3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

  • PRINCIPAL DISPLAY PANEL - 20 Extended-Release Tablet Blister Pack Carton

    NDC 41415-998-20

    12-HOUR

    mucusreliefDM

    GUAIFENESIN 600 mg &
    DEXTROMETHORPHAN HBr 30 mg
    EXTENDED-RELEASE TABLETS

    EXPECTORANT &
    COUGH SUPPRESSANT

    12 Hour

    • Controls Cough
    • Thins and Loosens Mucus
    • Immediate and Extended Release

    20
    EXTENDED-RELEASE
    TABLETS

    †Compare to the active
    ingredients of Mucinex® DM

    PRINCIPAL DISPLAY PANEL - 20 Extended-Release Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HBR 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-998
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-998-201 in 1 CARTON07/01/2021
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21478107/01/2021
    Labeler - PUBLIX SUPER MARKETS, INC (006922009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(41415-998)
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