WAL SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WALGREEN COMPANY]

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  • WAL SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WALGREEN COMPANY]

WAL SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WALGREEN COMPANY]
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NDC 0363-6850-08
Set ID f8512422-56b1-4e85-b605-c02ff34af706
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each chewable tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • reduces time to fall asleep if you have difficulty falling asleep
    • for relief of occasional sleeplessness
  • 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 (1-800-222-1222) right away.

  • Directions

    • do not take more than directed
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Walgreens

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

    NDC 0363-6850-08

    Wal-Sleep Z®

    DIPHENHYDRAMINE HCl, 25 mg / CHEWABLE TABLETS

    NIGHTTIME   SLEEP-AID   CHEWABLE

    Non-habit forming

    Not for treating Cold or Flu

    Chew or crush tablets completely before swallowing.
    Do not swallow tablets whole.

    24 CHEWABLE
    TABLETS

    GRAPE FLAVOR

    ACTUAL SIZE

    †Walgreens Pharmacist Survey

    ††This product is not manufactured or
    distributed by Procter & Gamble, owner of
    the registered trademark VICKS® ZzzQuil®
    NIGHTTIME SLEEP-AID.

    50844 ORG041868508

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2018 Walgreen Co.

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Walgreens 44-685

    Walgreens 44-685

  • INGREDIENTS AND APPEARANCE
    WAL SLEEP Z 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code 44;685
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6850-084 in 1 CARTON02/07/2018
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33802/07/2018
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-6850)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-6850)
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