Label: MUCUS RELIEF DM- dextromethorphan hydrobromide 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 November 2, 2020

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purpose

    Cough suppressant

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to 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 accompanied by 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 (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 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 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredients of MUCINEX® FAST-MAX® DM MAX

    for ages 12+

    maximum Strength

    FAST

    Mucus Relief

    DM Max

    multi-Symptom

    Dextromethorphan HBr 20 mg

    Cough Suppressant

    Guaifenesin 400 mg

    Expectorant

    Relieves

    Chest Congestion

    Controls Cough

    Thin & Loosens Mucus

    4 Hour Dosing

    *Mucinex® Fast-Max® DM Max is a registered trademark of Reckitt Benckiser, Slough, UK. Reckitt Benckiser is not affiliated with The Kroger Co. or this product

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

    DISTRIBUTED BY: THE KROGER CO.

    CINCINNATI, OHIO 45202

    www.kroger.com

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg

    KROGER Maximum Strength Mucus Relief DM

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hydrobromide guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-508
    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 RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-508-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2020
    Labeler - The Kroger Co. (006999528)
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