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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2022

If you are a consumer or patient please visit this version.

  • 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 FINALpart34105/23/2013
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)