Label: MUCUS RELIEF DM AND OVERNIGHT COLD AND FLU- dextromethorphan hbr, guaifenesin, acetaminophen and triprolidine hcl kit

  • 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 5, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)
    Maximum Strength Mucus Relief DM Max
    Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Active ingredients (in each 20 mL)Purposes
    Nighttime Cold & Flu

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Triprolidine HCl 2.5 mg

    Antihistamine

  • Uses

    MAXIMUM STRENGTH MUCUS RELIEF DM

    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 imitants
    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 that directed

    Stop use and ask a doctor if

    cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition.

    If pregnancy 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 Centre right away at 1-800-222-1222

  • 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 (Maximum strength mucus relief DM)

    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

  • Uses (Nighttime Cold and Flu)

    temporarily relieves these common cold and flu symptoms:
    cough
    minor aches and pains
    sore throat
    headache
    runny nose
    sneezing
    itching of the nose or throat
    itchy, watery eyes due to hay fever
    temporarily reduces fever
    controls cough to help you get to sleep
  • Warnings

    Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\

    more than 4000 mg in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks daily while using this product

    If pregnant or breast feeding

    Ask a health professional before use

    Keep Out of Reach of Children

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222.

    Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

    Directions

    do not take more than directed (see overdose warnings
    do not take more than 4 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 and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours
    children under 12 years of age: do not use

    Other Information

    each 20 mL contains: sodium 10 mg
    low sodium
    store at room temperature
    do not refrigerate
  • Inactive ingredients (Overnight Cold & Flu)

    anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    (1-866-467-2748)

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    VALUE PACK

    NDC 0363-3998-12

    Compare to the active ingredients Maximum Strength Mucinex® Fast Max® DM Max*

    Mucus Relief DM

    Dextromethorphan HBr • Cough Suppressant
    Guaifenesin • Expectorant
    MAXIMUM STRENGTH

    MULTI-SYMPTOM

    Relieves chest congestion & cough
    Thins & loosens mucus
    4 hour dosing
    12 years & older

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

    Compare to Mucinex® Nightshift Cold & Flu Active Ingredients**

    Nighttime Cold & Flu

    ACETAMINOPHEN • PAIN RELIEVER/FEVER REDUCER
    DEXTROMETHORPHAN HBR • COUGH SUPPRESSANT

    TRIPROLIDINE HCL • ANTIHISTAMINE

    MULTI-SYMPTOM

    Maximum Strength per 4-hour dose

    Nighttime relief for a better morning
    Relieves cough, fever, sore throat, runny nose & sneezing
    Maximum Strength per 4-hour dose
    12 years & older

    2 – 6 FL OZ (180 mL) BOTTLES / TOTAL 12 FL OZ (360 mL)

    ††These product is not manufactured or distributed by Reckitt Benckister Health, distributor of Maximum Strength Mucinex® Fast Max© DM Max & Mucinex© Nightshift Cold & Flu.

    TAMPER EVIDENT: DO NOT TAKE MAXIMUM STRENGTH MUCUS RELIEF DM & OVERNIGHT COLD & FLU LIQUIDS AT THE SAME TIME.

    Walgreens Pharmacist Recommended

    Walgreens Pharmacist Survey

    See bottle for full labeling.

    Walgreens DM Max and Nighttime Cold and Flu Combo Pack
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM AND OVERNIGHT COLD AND FLU 
    dextromethorphan hbr, guaifenesin, acetaminophen and triprolidine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3998
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3998-121 in 1 CARTON; Type 0: Not a Combination Product03/30/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    MAXIMUM STRENGTH MUCUS RELIEF DM 
    dextromethorphan hbr and guaifenesin solution
    Product Information
    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)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Part 2 of 2
    OVERNIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hbr and triprolidine hcl solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 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)  
    glycerin (UNII: PDC6A3C0OX)  
    propyl gallate (UNII: 8D4SNN7V92)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Labeler - WALGREENS CO (008965063)