Label: WALGREENS NIGHTTIME KIDS HONEY COLD COUGH CONGESTION- doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 15 mL)

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

    Purpose

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold symptoms:

    ▪
    nasal congestion
    ▪
    sinus congestion & pressure
    ▪
    cough due to minor throat & bronchial irritation
    ▪
    cough to help you sleep
    ▪
    runny nose & sneezing
    ▪
    reduces swelling of nasal passages
    ▪
    temporarily restores freer breathing through the nose
    ▪
    promotes nasal and/or sinus drainage
  • 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.
    ▪
    to make a child sleepy

    Ask a doctor before use if you have

    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    thyroid disease
    ▪
    diabetes
    ▪
    glaucoma
    ▪
    trouble urinating due to enlarged prostate gland
    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    a breathing problem or chronic cough that lasts or 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.
    ▪
    excitability may occur, especially in children
    ▪
    marked drowsiness may occur
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness
    ▪
    avoid alcoholic drinks
    ▪
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    ▪
    you get nervous, dizzy or sleepless
    ▪
    symptoms do not improve within 7 days or occur with a fever
    ▪
    cough persists for more than 7 days, comes back or occurs with a 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.

    Overdose warning

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

  • Directions

    ▪
    take only as directed
    ▪
    only use dose cup provided
    ▪
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 6 to under 12 yrs

    15 mL every 4 hrs

    children 4 to under 6 yrs

    do not use unless directed by a doctor

    children under 4 yrs

    do not use

  • Other information

    •
    each 15 mL contains: sodium 12 mg
    •
    store at room temperature
  • Inactive ingredients

    Anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, , xanthan gum

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Distributed by:

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    Compare to the active ingredients in Kids Vicks® NyQuil™ Honey Cold & Cough + Congestion*

    NDC 0363-6248-08

    Nighttime

    Kid’s

    Cold & Cough + Congestion

    Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr

    •
    Sneezing, Runny Nose
    •
    Nasal Congestion
    •
    Cough

    No Added Alcohol & Acetaminophen Free

    Honey Flavor

    Naturally and Artificially Flavored

    8 FL OZ (236 mL)

    *This Product is not manufactured or distributed by Procter & Gamble, the distributor of Kids Vicks® NyQuil™ Honey Cold & Cough + Congestion.

    WAG Nighttime Kids Cold & Cough + Congestion 8 Fl Oz 236 ml
  • INGREDIENTS AND APPEARANCE
    WALGREENS NIGHTTIME KIDS  HONEY COLD COUGH CONGESTION
    doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6248
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6248-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2023
    Labeler - WALGREENS CO (008965063)
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