Label: LEADER MAXIMUM STRENGTH MUCUS RELIEF DM- 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 January 11, 2022

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

View All Sections
  • 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

    LEADER™
    NDC 70000-0465-1


    Maximum Strength
    Mucus
    Relief DM


    Dextromethorphan HBr, 20 mg
    Guaifenesin, 400 mg

    Cough Suppressant / Expectorant


    For Ages 12 & Over
    Multi-Symptom

    Relieves Chest Congestion    
    Controls Cough   

    Thins and loosens Mucus

    COMPARE TO MUCINEX FAST MAX DM MAX active ingredients*
    6 FL OZ (177 mL)

    119


  • INGREDIENTS AND APPEARANCE
    LEADER MAXIMUM STRENGTH MUCUS RELIEF DM 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0465
    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:70000-0465-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/23/2019
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!