Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

  • NDC Code(s): 58602-715-05, 58602-715-06, 58602-715-09, 58602-715-10, view more
    58602-715-15, 58602-715-57, 58602-715-60, 58602-715-64, 58602-715-65, 58602-715-68, 58602-715-69, 58602-715-70
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 3, 2024

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  • Active ingredients

    (in each extended-release tablet)
    Dextromethorphan Hydrobromide USP 60 mg
    Guaifenesin USP 1200 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 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 (1-800-222-1222) right away.

  • 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


    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients


    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

  • Questions?


    call 1-855-274-4122  You may also report side effects to this phone number.

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)

    NDC 58602-715-05
    MAXIMUM STRENGTH
    Mucus Relief DM
    Guaifenesin and Dextromethorphan HBr
    Extended-release Tablets
    1200 mg/60 mg
    EXPECTORANT AND COUGH SUPPRESSANT
    12 HOUR
    Controls Cough
    Thins and Loosens Mucus
    14 Extended-release Tablets
    AUROHEALTH

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

    Compare to the active ingredients of
    Maximum Strength Mucinex® DM*
    NDC 58602-715-05
    Mucus Relief DM
    MAXIMUM STRENGTH
    Guaifenesin and Dextromethorphan HBr
    Extended-release Tablets
    1200 mg/60 mg
    EXPECTORANT AND
    COUGH SUPPRESSANT
    12 HOUR
    Controls Cough
    Thins and Loosens Mucus
    14 Extended-release Tablets
    AUROHEALTH

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

    Comparative to the active ingredients of
    Maximum Strength Mucinex® DM*
    NDC 58602-715-70
    MAXIMUM STRENGTH
    Mucus Relief DM
    Guaifenesin and
    Dextromethorphan HBr
    Extended-release Tablets
    1200 mg/60 mg
    EXPECTORANT AND
    COUGH SUPPRESSANT
    12 HOUR
    Controls Cough
    Thins and Loosens Mucus
    28 (4 x7)
    Extended-release Tablets
    AUROHEALTH

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HBR 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-715
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code X;63
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-715-051 in 1 CARTON03/17/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-715-571 in 1 CARTON03/17/2017
    228 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-715-091 in 1 CARTON03/17/2017
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-715-681 in 1 CARTON03/17/2017
    438 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-715-601 in 1 CARTON03/17/2017
    542 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-715-691 in 1 CARTON03/17/2017
    644 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-715-151 in 1 CARTON03/17/2017
    760 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-715-704 in 1 CARTON03/17/2017
    87 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:58602-715-066 in 1 CARTON03/17/2017
    97 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:58602-715-652 in 1 CARTON03/17/2017
    107 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:58602-715-106 in 1 CARTON03/17/2017
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    12NDC:58602-715-641 in 1 CARTON03/17/2017
    127 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20694103/17/2017
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-715) , MANUFACTURE(58602-715)
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