Label: ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, liquid filled

  • NDC Code(s): 0031-8719-10, 0031-8719-20, 0031-8719-31, 0031-8719-70
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 15, 2024

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  • Active ingredients (in each liquid-filled capsule)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 200 mg

    Purposes

    Cough suppressant

    Expectorant

  • Uses

    •
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Do not use 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

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by 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.

  • Directions

    •
    do not take more than 12 capsules in any 24-hour period
    •
    this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    2 capsules every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    store at 20-25°C (68-77°F).
    •
    avoid excessive heat above 40°C (104°F).
  • Inactive ingredients

    FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

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

    Made in Canada

    For most recent product information, visit www.robitussin.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    ADULT

    Robitussin®

    MAXIMUM
    STRENGTH

    Cough+Chest
    Congestion DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    DM
    MAX

    Relieves:

    •
    Cough
    •
    Mucus

    Non-Drowsy

    For Ages 12 & Over

    20
    LIQUID-FILLED
    CAPSULES

    PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hydrobromide and guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8719
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorRED (clear red) Scoreno score
    ShapeOVAL (oblong) Size16mm
    FlavorImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8719-105 in 1 CARTON05/02/2016
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0031-8719-2010 in 1 CARTON05/23/2013
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0031-8719-3115 in 1 CARTON05/23/201312/31/2018
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0031-8719-70500 in 1 BOX05/23/201312/31/2018
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/23/2013
    Labeler - Haleon US Holdings LLC (079944263)
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