Label: ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF- dextromethorphan hydrobromide, guaifenesin tablet, extended release

  • NDC Code(s): 0031-8765-04, 0031-8765-08, 0031-8765-16
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 7, 2024

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  • Active ingredients (in each extended-release tablet)

    Dextromethorphan HBr 60 mg

    Guaifenesin 1200 mg

  • Purposes

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    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

    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).

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    • each tablet contains:magnesium 25 mg
    • store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • QUESTIONS

    Questions?

    call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • Principal Display Panel

    NEW!

    Robitussin ®

    MAXIMUM STRENGTH
    12 Hour
    Cough & Mucus Relief

    EXTENDED-RELEASE TABLETS

    GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
    1200 mg/60 mg EXTENDED-RELEASE TABLETS

    Expectorant & Cough Suppressant

    Actual Size

    ✓Controls Cough

    ✓Thins & Loosens Mucus

    8EXTENDED-RELEASE TABLETS

    Robitussin 12 Hr Cough 1200mg/60mg ER Tabs
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF 
    dextromethorphan hydrobromide, guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8765
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code 2424
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8765-041 in 1 CARTON06/14/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0031-8765-081 in 1 CARTON06/14/2019
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0031-8765-162 in 1 CARTON06/14/2019
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20760206/14/2019
    Labeler - Haleon US Holdings LLC (079944263)
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