Label: COUGH AND CHEST CONGESTION DM MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin liquid

  • 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 June 13, 2023

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

  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purposes

    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

    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 that occurs with 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 headache that lasts. 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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • dose as follows or as directed by a doctor
    • adults and children 12 years of age and older: 20 mL every 4 hours
    • children under 12 years of age: do not use

  • Other information

    • each 20 mL contains: sodium 20 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • Question or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Compare to the active ingredients in Delsym® Cough+™ Chest Congestion DM††

    Cough & Chest

    Congestion DM

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    GUAIFENESIN / EXPECTORANT

    Maximum Stength

    • Relieves cough & chest congestion
    • Thins & loosens mucus
    • For ages 12 & over

    Cherry flavor

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND AND UNDER CAP IS BROKEN OR MISSING

    ††This product is not manufactured or distributed by RB Health (US) LLC, owner of the trademark Delsym® Cough+™ Chest Congestion DM.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg

    WALGREENS Cough and Chest Congestion DM Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    COUGH AND CHEST CONGESTION DM  MAXIMUM STRENGTH
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0506
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0506-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/29/2016
    Labeler - Walgreens (008965063)