Label: WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH- dextromethorphan hbr, doxylamine succinate 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 7, 2017

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

  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr ,USP 30 mg

    Doxylamine Succinate, USP 12.5 mg

  • Purposes

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation

    as may occur with a cold.

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
    controls the impulse to cough to help you sleep
  • Warnings

    Do not use

    to sedate a child or to make a child sleepy
    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

    trouble urinating due to an enlarged prostate gland
    glaucoma
    a cough that occurs with too much phlegm (mucus)
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product do not use more than directed

    do not use more than directed
    marked drowsiness may occur
    avoid alcoholic drinks
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery
    excitability may occur, especially in children

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or is accompanied by 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 1-800-222-1222.

  • Directions

    measure only with dosing cup provided
    keep dosing cup with product
    mL= milliliter.
    do not take more than 4 doses in any 24-hour period.
    this adult product is not intended for use in children under 12 years of age.

    age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    do not use

  • Other information:

    each 20mL contains: sodium 4 mg
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C red no. 40, flavors, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

    DO NOT USE IF INNER SEAL IS BROKEN OR MISSING

  • Principal Display Panel

    Walgreens

    Compare to Robitussin® Maximum Strength Nighttime Cough DM active ingredients‡

    NDC 0363-0758-04

    ADULT

    Nighttime

    Wal-Tussin®

    DM Max

    COUGH

    DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT

    DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE

    MAXIMUM STRENGTH

    Relieves cough, itchy throat & runny nose
    12 Years & older

    Walgreens Pharmacist Survey

    WALGREENS PHARMACIST RECOMMENDED‡

    ‡‡This product is not manufactured or distributed by Pfizer distributor of Robitussin® Maximum Strength Nighttime Cough DM

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD.,DEERFIELD,IL 60015

    Walgreens 100% SATISFACTION GUARANTEED

    Walgreens.com ©2017 Walgreen Co.

    4 FL OZ (118 mL)

    Walgreens Adult Nighttime Wal-Tussin DM Max Maximum Strength 4 FL OZ (118 mL)
  • INGREDIENTS AND APPEARANCE
    WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0758
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0758-041 in 1 CARTON09/08/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/08/2017
    Labeler - WALGREEN CO. (008965063)