Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride solution

  • NDC Code(s): 0363-7300-12, 0363-7300-24
  • Packager: WALGREEN COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL dose cup)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    ▪
    for the relief of occasional sleeplessness
    ▪
    reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    ▪
    for children under 12 years of age
    ▪
    with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    ▪
    a breathing problem such as emphysema or chronic bronchitis
    ▪
    glaucoma
    ▪
    difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    ▪
    avoid alcoholic beverages

    Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    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 at 1-800-222-1222

  • Directions

    ▪
    take only one dose per day (24 hours)
    ▪
    only use the dose cup provided

    adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use
  • Other information

    •
    each 30 mL dose cup contains: potassium 5 mg; sodium 10 mg
    •
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel - 354 mL Label

    Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

    Nighttime Sleep-aid

    Diphenhydramine HCl

    Non-Habit Forming

    Makes you fall asleep fast

    Alcohol-Free

    Cherry Vanilla Flavor

    Naturally and Artificially Flavor

    Not for Pain, Not for Colds, Just for Sleep

    12 FL. OZ. (354 ml)

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens.com ©2017 Walgreen Co.

    Package Label for Nighttime Sleep-Aid

    Walgreen Nighttime Sleep-aid Diphenhydramine HCL

    Package Label for Nighttime Sleep Aid Twin-Pack

    Nighttime Sleep Aid Dihenhydramine HCl
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRY, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7300-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2020
    2NDC:0363-7300-242 in 1 CELLO PACK01/25/2020
    2354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/25/2020
    Labeler - WALGREEN COMPANY (008965063)
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