Label: CVS MUCUS RELIEF DM MAXIMUM STRENGTH- dextromethorphan hbr 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 September 14, 2023

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

  • 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

    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 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 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
    low sodium
    store at room temperature
    do not refrigerate
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 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

    NDC# 69842-937-06

    *Compare to Maximum Strength Mucinex® Fast-Max® DM max active ingredients††

    DM Max

     
    DEXTROMETHORPHAN HBr/COUGH SUPPRESSANT
    GUAIFENESIN 400 mg/ EXPECTORANT

    MAXIMUM STRENGTH

    MULTI-SYMPTOM

    Relieves Chest Congestion & cough
    Thins & Loosens Mucus
    4 Hour Dosing
    12 years & older

    For Ages 12+

    6 FL OZ (180 mL)

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

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    Walgreens.com © 2020 Walgreen Co.

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast -Max® DM Max.

    CVS Mucus Relief DM Maximum Strength
  • INGREDIENTS AND APPEARANCE
    CVS MUCUS RELIEF DM  MAXIMUM STRENGTH
    dextromethorphan hbr and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-937
    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:69842-937-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Labeler - CVS PHARMACY (062312574)