WAL TUSSIN DM MAX NIGHTTIME WAL TUSSIN DM MAX (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN) KIT [WALGREEN COMPANY]

WAL TUSSIN DM MAX NIGHTTIME WAL TUSSIN DM MAX (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN) KIT [WALGREEN COMPANY]
PDF | XML

NDC 0363-0913-12, 0363-1023-26
Set ID d7a00a92-7d41-4a6e-b84c-9e20514cbc4a
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each 20mL) - NIGHTTIME

    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 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
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    persistent or chronic cough such as occurs with smoking, asthma, 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
    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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (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 20 mL contains: sodium 11 mg
    store at 20-25°C (68-77°F)
  • Inactive Ingredients

    anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Active ingredients (in each 20 mL) - DAYTIME

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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

    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

  • Directions

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    mL = milliliter
    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 4 hours

    children under 12 years

    do not use

  • Other information

    each 20 mL contains: sodium 13 mg
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive Ingredients

    acetic acid, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    DAY & NIGHT PACK

    Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM & Robitussin® Maximum Strength Nighttime Cough DM active ingredients

    ADULT

    NON-DROWSY

    Wal-Tussin®

    DM Max

    COUGH & CHEST CONGESTION DM

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    GUAIFENESIN / EXPECTORANT

    MAXIMUM STRENGTH

    ALCOHOL FREE

    Relieves cough, chest congestion & mucus

    For maximum strength mucus relief

    12 years & older

    SEE NEW DOSING

    RASPBERRY MENTHOL FLAVOR

    ADULT

    Nighttime Wal-Tussin® DM Max

    COUGH

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    DOXYLAMINE SUCCINATE / ANTIHISTAMINE

    MAXIMUM STRENGTH

    ALCOHOL FREE

    Relieves cough, itchy throat & runny nose

    12 years & older

    SEE NEW DOSING

    RASPBERRY, BLACKBERRY & MENTHOL FLAVOR

    TOTAL 8 FL OZ (236 mL) – 2 x 4 FL OZ (118 mL)

    Wal-Tussin DM Max Nighttime Wal-Tussin DM Max Carton Image 1
    Wal-Tussin DM Max Nighttime Wal-Tussin DM Max Carton Image 2
  • INGREDIENTS AND APPEARANCE
    WAL TUSSIN DM MAX NIGHTTIME WAL TUSSIN DM MAX 
    dextromethorphan hbr, doxylamine succinate, guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0913
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0913-121 in 1 CARTON; Type 0: Not a Combination Product10/27/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    NIGHTTIME WAL TUSSIN DM MAX 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    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
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart341
    Part 2 of 2
    WAL TUSSIN DM MAX 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Item Code (Source)NDC:0363-1023
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1023-26118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/27/2018
    Labeler - Walgreen Company (008965063)

Related Drugs