Label: MAXIMUM STRENGTH MUCUS RELIEF DM- dextromethorphan hydrobromide and guaifenesin solution

  • 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 October 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    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

    ▪
    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 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 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 at 1-800-222-2222.

  • 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
    ▪
    mL = milliliter
    ▪
    Adults and children 12 years and older: 20 mL every 4 hours
    ▪
    Children under 12 years of age: Do not use
  • Other information

    ▪
    each 20 mL contains: sodium 8 mg
    ▪
    store at room temperature
    ▪
    do not refrigerate
    ▪
    dosing cup provided
    ▪
    low sodium
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue#1,FD&C red #40, flavors, potassium citrate , propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose ,xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

    LEADER

    NDC 70000-0129-1

    Maximum Strength

    Mucus Relief DM

    Dextromethorphan HBr ǀ Guaifenesin
    Cough Suppressant ǀ Expectorant

    COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST MAX® DM MAX active ingredients*

    100% Money back Guarantee

    For Ages 12+

    •
    Controls Cough
    •
    Relieves Chest Congestion
    •
    Thins & Loosens Mucus
    •
    4 Hour Dosing
    •
    Maximum Strength Formula

    6 FL OZ (180 mL)

    Tamper evident: do not use if printed seal under cap is broken or missing.

    ©2017 Cardinal Health, All Rights Reserved , CARDINAL HEALTH ,the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

    Essential to care™ since 1979

    *This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademarks

    Maximum Strength Mucinex® Fast -Max® DM Max.

    Leader Maximum Strength Mucus Relief DM 6 FL OZ
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF DM 
    dextromethorphan hydrobromide and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0129
    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)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propyl gallate (UNII: 8D4SNN7V92)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0129-1180 mL in 1 BOTTLE; Type 0: Not a Combination Product03/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/06/2017
    Labeler - CARDINAL HEALTH (063997360)
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