WALTUSSIN DM MAX (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN) KIT [WALGREEN COMPANY]

WALTUSSIN DM MAX (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN) KIT [WALGREEN COMPANY]
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NDC 0363-0702-26, 0363-0918-12
Set ID 95ab0fa0-9c3c-48bd-a9bd-cb41798d1c1f
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Nighttime Cough DMActive ingredients (in each 10 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 - Daytime

    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

    10 mL

    every 6 hours

    children under 12 years

    do not use

  • Other information

    each 10 mL contains: sodium 8 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Daytime Cough + Chest Congestion DMActive ingredients (in each 10 mL)

    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 or 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

    shake well before using
    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

    10 mL

    every 4 hours

    children under 12 years

    do not use

  • Other information

    each 10 mL contains: sodium 7 mg
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    DAY & NIGHT PACK

    ADULT – NON-DROWSY

    Wal-Tussin® DM Max

    DM MAX

    COUGH & CHEST CONGESTION

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    GUAIFENESIN / EXPECTORANT

    MAXIMUM STRENGTH

    ALCOHOL FREE

    Relieves cough, chest congestion & mucus

    For maximum strength mucus relief

    12 years & older

    CHERRY & MENTHOL FLAVOR

    DAYTIME

    CHERRY & MENTHOL FLAVOR

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

    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

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

    WalTussin DM Max Daytime Nighttime Carton Image 1
    WalTussin DM Max Daytime Nighttime Carton Image 2
  • INGREDIENTS AND APPEARANCE
    WALTUSSIN DM MAX 
    dextromethorphan hbr, doxylamine succinate, guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0918
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0918-121 in 1 KIT; Type 0: Not a Combination Product07/10/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    WAL TUSSIN DM MAX 
    dextromethorphan hbr, guaifenesin suspension
    Product Information
    Item Code (Source)NDC:0363-0702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorRED (Opaque) Score    
    ShapeSize
    FlavorCHERRY (menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0702-26118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/31/2014
    Part 2 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 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorRED (clear) Score    
    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 finalpart34107/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/10/2016
    Labeler - Walgreen Company (008965063)

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