Label: WALGREENS DAY AND NIGHT PACK- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate 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 12, 2022

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  • Children’s Daytime Wal-Tussin® DM

  • Active ingredients Day Time (in each 20 mL)

    Dextromethorphan HBr USP 20 mg

    Guaifenesin. USP 200 mg

  • Children’s Nighttime Wal-Tussin® DM

  • Active ingredients for Nighttime (in each 10 mL)

    Chlorpheniramine maleate, USP 2 mg

    Dextromethorphan HBr USP 15 mg

  • Purposes for Daytime Wal-Tussin® DM

    Cough suppressant

    Expectorant

  • Purpose for Nighttime Wal-Tussin® DM

    Antihistamine

    Cough suppressant

  • Uses

    DAYTIME

    •
    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

    NIGHTTIME

    •
    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
    ▪
    itching of the nose or throat 
    ▪
    itchy, watery eyes
  • Warnings

    Do not us

    DAYTIME

    •
    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.

    NIGHTTIME

    •
    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

    DAYTIME

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

    NIGHTTIME

    •
    trouble urinating due to an enlarges 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

    NIGHTTIME

    taking sedatives or tranquilizers.

    When using this product

    NIGHTTIME

    •
    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

    DAYTIME

    •
    cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    NIGHTTIME

    •
    cough last 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,

    DAYTIME

    ask a health professional before use.

    NIGHTTIME

    ask a health professional before use

    Keep out of reach of children.

    DAYTIME

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    NIGHTTIME

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Directions

    Daytime Wal-Tussin® DM

    •
    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

    age

    dose

    Children under 4 years

    Do not use

    Children 4 to under 6 years

    5 mL every 4 hours

    Children 6 to under 12 years

    10 mL every 4 hours

    Adults and children 12 years and older

    20 mL every 4 hours


    Nighttime Wal-Tussin® DM

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

    age

    dose

    Children under 6 years

    Do not use

    Children 6 to under 12 years

    10 mL every 6 hours

    Adults and children 12 years and older

    20 mL every 6 hours
  • Other information

    DAYTIME Wal-Tussin DM

    •
    each 20 mL contains: sodium 11 mg
    •
    store at room temperature. Do not refrigerate
    •
    contain low sodium
    •
    do not use if printed seal under cap is torn or missing

    Nighttime Wal-Tussin DM

    •
    each 10 mL contains: sodium 6 mg
    •
    store at room temperature. Do not refrigerate
    •
    contain low sodium
    •
    do not use if printed seal under cap is torn or missing
  • Inactive ingredients

    Inactive ingredients for Day Time Wal-Tussin DM 

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

    Inactive ingredients for Night Time Wal-Tussin DM 

    anhydrous citric acid, FD&C Red No. 40, natural and artificial flavors, glycerin, lactic acid, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to Children's Robitussin® Cough & Chest Congestion DM* & Nighttime Cough DM Long-Active active ingredients††

    Children's

    Cough & Chest Congestions DM

    Wal-Tussin® DM

    DEXTROMETHORPHAN HBr, USP 20 mg/ 20 mL

    COUGH SUPPRESSANT

    GUAIFENESIN, USP 200 mg

    EXPECTORANT

    DAYTIME

    NON-DROWSY

    Relieves cough, chest congestion & mucus

    4 YEARS & OVER

    GRAPE FLAVOR

    Naturally and Artificially Flavored

    Dosage cup included

    2 - 4 FL OZ (118 mL) BOTTLES / TOTAL – 8 FL OZ (236 mL)

    ††This product is not manufactured or distributed by Pfizer, the distributor of Children’s Robitussin® Cough & Chest Congestion DM.

    Children's

    Nighttime Cough DM

    Wal-Tussin® DM

    CHLORPHENIRAMINE MALEATE, USP 2 mg / 10 mL

    ANTIHISTAMINE

    DEXTROMETHORPHAN HBr, USP 15 mg / 10 mL

    COUGH SUPPRESSANT

    NIGHTTIME

    •
    Relieves cough & runny nose

    Alcohol free

    6 YEARS & OLDER

    Fruit Punch Flavor

    Naturally and Artificially Flavored

    Dosage cup included

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

    ††This product is not manufactured or distributed by Pfizer, the distributor of Children’s Robitussin® Nighttime Cough DM Long-Acting.

    Walgreens

    PHARMACIST RECOMMENDED

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

    DISTRIBUTED BY: WALGREENS CO.

    200 WILMOT RD. DEERFIELD, IL 60015

    Walgreens 10% SATISFACTION GUARANTEED

    walgreens.com ©2020 Walgreen Co.

    Walgreens Childrens Day Time & Nighttime Wal Tussin DM Twin Pack
  • INGREDIENTS AND APPEARANCE
    WALGREENS DAY AND NIGHT PACK 
    dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7570
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7570-081 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)04/13/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    DAYTIME COUGH AND CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin liquid
    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) GUAIFENESIN200 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 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 finalpart34104/13/2020
    Part 2 of 2
    NIGHT TIME COUGH DM 
    chlorpheniramine maleate, diphenhydramine hbr liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 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 finalpart34104/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/13/2020
    Labeler - WALGREEN CO (008965063)
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