Label: SLEEP AID- diphenhydramine hcl solution

  • NDC Code(s): 0363-8020-02, 0363-8020-45, 0363-8020-96
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 6, 2023

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  • Active ingredient (in each 30 mL)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for 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.

  • Directions

    • do not take more than directed
    • mL = milliliter
    • only use the dose cup provided
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each 30 mL contains: sodium 17 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    NDC 0363-8020-02

    Walgreens

    Compare to the active ingredient in
    Vicks® ZzzQuil® Nighttime Sleep-Aid††

    WALGREENS
    PHARMACIST RECOMMENDED†

    Sleep Aid
    DIPHENHYDRAMINE HCl 50 mg per 30 mL /
    NIGHTTIME SLEEP AID

    Nighttime

    • Non-habit forming

    Ages 12 Years & Over

    12 FL OZ (355 mL)

    Berry
    flavor

    NOT FOR COLDS OR FOR PAIN

     TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    †Our pharmacists recommend the Walgreens brand.
    We invite you to compare to national brands.
    ††This product is not manufactured or distributed by The
    Procter & Gamble Company, owner of the registered
    trademark Vicks® ZzzQuil® Nighttime Sleep-Aid.

    50844     REV0223A00202

    DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED     walgreens.com ©2021 Walgreen Co.

    Walgreens 44-002A

    Walgreens 44-002A

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8020
    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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8020-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2022
    2NDC:0363-8020-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2022
    3NDC:0363-8020-962 in 1 PACKAGE03/10/2022
    3355 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 DrugM01003/10/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(0363-8020) , pack(0363-8020)
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