Label: WALGREENS CHILDRENS- nighttime cough liquid

  • 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 December 28, 2021

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  • Active ingredients (in each 10 mL)

    Chlorpheniramine maleate, USP 2 mg

    Dextromethorphan HBr USP 15 mg

  • Purpose

    Antihistamine

    Cough suppressant

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

    Do not us

    •
    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 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

    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 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,

    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 (1-800-222-1222) right away

  • 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

    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

    •
    each 10 mL contains: sodium 3 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

    anhydrous citric acid, FD&C Red # 40, flavor, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to the Children's Robitussin® Nighttime Cough DM active ingredients††

    NDC# 0363-7560-04

    Children's

    Nighttime Cough

    Wal-Tussin® DM

    CHLORPHENIRAMINE MALEATE, USP 2 mg/10 mL

    ANTIHISTAMINE

    DEXTROMETHORPHAN HBr, USP 15 mg/15 mL

    COUGH SUPPRESSANT

    NIGHTTIME

    Relieves cough & runny nose

    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)

    Walgreens PHARMACIST RECOMMENDED†

    Health expertise you rely on, quality you trust

    †Walgreens Pharmacists Survey

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin®

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens

    100% SATISFACTION GUARANTEED

    Walgreens.com ©2020 Walgreen Co.

    Walgreens Childrens Nighttime Cough 188 mL
  • INGREDIENTS AND APPEARANCE
    WALGREENS CHILDRENS 
    nighttime cough liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7560
    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
    1NDC:0363-7560-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/16/2019
    Labeler - WALGREENS CO. (008965063)
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