WAL-SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

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  • WAL-SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

WAL-SLEEP Z (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0672-12, 0363-0672-19, 0363-0672-51
Set ID 7d8e88d0-c594-4bb3-893f-1654c84a1bea
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 caplet)

    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
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep aid.

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • use caution when driving a motor vehicle or operating machinery

    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
    • adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each caplet contains: calcium 70 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • avoid excessive heat (greater than 100°F) or humidity
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal display panel


    Walgreens

    Compare to VICKS®
    ZzzQuil® active ingredient††

    NDC 0363-0672-12

    Wal-Sleep Z®

    DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

    NIGHTTIME      CAPLETS

    • Non-habit forming

    8
    CAPLETS

    Actual Size

    NOT FOR
    TREATING
    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 Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil®.

    50844     ORG021567219

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

    ORG1018-F

    Walgreens 44-672

    Walgreens 44-672

  • INGREDIENTS AND APPEARANCE
    WAL-SLEEP Z 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0672
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 44;672
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0672-191 in 1 CARTON07/24/2015
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0672-121 in 1 PACKAGE07/24/2015
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0672-51365 in 1 BOTTLE; Type 0: Not a Combination Product07/24/201510/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33807/24/2015
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-0672)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0672)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0363-0672)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(0363-0672) , PACK(0363-0672)
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