Label: MAXIMUM STRENGTH MUCUS RELIEF DM MAX- dextromethorphan hbr, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2025

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

  • ACTIVE INGREDIENTS (in each 20 mL)

    Dextromethorphan HBr, 20 mg

    Guaifenesin, 400 mg


  • PURPOSE

    Cough Suppressant

    Expectorant


  • USE(S)

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

  • 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


    • 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 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 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 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • Adults & children 12 years & older: 20 mL every 4 hours
    • Children under 12 years of age: Do not use






  • OTHER INFORMATION

    • each 20 mL contains: potassium 20 mg, sodium 20 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided
  • INACTIVE INGREDIENTS

    citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40,  flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    TopCare® health

     
    NDC 76162-628-58

    COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX DM MAX ACTIVE INGREDIENTS*

     

    MAXIMUM STRENGTH


    Mucus Relief

    DM Max

     


    DEXTROMETHORPHAN HBr 20 mg

    COUGH SUPPRESSANT
    GUAIFESNESIN 400 mg

    EXPECTORANT


    • Controls Cough
    • Relieves Chest Congestion
    • Thins & Loosens Mucus
    • 4-Hour Dosing

     

     CHERRY FLAVOR   

     6 FL OZ (177 mL)  FOR AGES 12+

     

    628-6-topco.jpg

    628-6-topco-b.jpg

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF DM MAX 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-628
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-628-58177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/10/2025
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(76162-628)