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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 27, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    8 EXTENDED-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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)