WAL-SLEEP Z (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]

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WAL-SLEEP Z (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]
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NDC 0363-0654-02, 0363-0654-08, 0363-0654-22
Set ID 68c337c5-d17b-41d3-82d9-414d41e7d9c4
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 liquid-filled capsule)

    Diphenhydramine HCl 25 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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: take 2 capsules 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
    • protect from light
    • see end flap for expiration date and lot number
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat above 40ºC (104ºF) and high humidity
  • Inactive ingredients

    edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

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

     NDC 0363-0654-08

    Wal-Sleep Z®

     DIPHENHYDRAMINE  HCl 25 mg / NIGHTTIME SLEEP AID

    NIGHTTIME   SOFTGELS

    • Non-habit forming

    24
    SOFTGELS**
    (**LIQUID-FILLED CAPSULES)

    ACTUAL SIZE

    NOT FOR TREATING PAIN, COLD OR FLU

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

    †Walgreens Pharmacist Survey
    ††This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® ZzzQuil® Nighttime Sleep-Aid LiquiCaps®.

    50844   REV0319A65408

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2018 Walgreen Co.
    PRODUCT OF CHINA PACKAGED AND
    QUALITY ASSURED IN THE U.S.A.

    Walgreens 44-654

    Walgreens 44-654

  • INGREDIENTS AND APPEARANCE
    WAL-SLEEP Z 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0654
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 654
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0654-082 in 1 CARTON02/28/2015
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0654-224 in 1 CARTON02/28/2015
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0654-021 in 1 CARTON02/28/2015
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33802/28/2015
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(0363-0654)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0654)
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