DYE FREE SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

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  • DYE FREE SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

DYE FREE SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-6270-12
Set ID e8d45ad1-8531-4b0c-84bd-554a1c8cb9d9
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

  • Use

    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

    • 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 right away. 

  • Directions

    • do not take more than directed 
    • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each caplet contains: calcium 30 mg 
    • protect from moisture
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch,dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel


    Walgreens

    Compare to Simply Sleep®
    active ingredient††

    NDC 0363-6270-12

    Dye-Free Sleep Aid

    DIPHENHYDRAMINE HCl 25 mg / 
    NIGHTTIME SLEEP AID

    DYE FREE   NIGHTTIME
    MINI CAPLETS

    • For a restful night's sleep
    • Does not contain pain reliever
    • Safe, non-habit forming

    100
     MINI-CAPLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Walgreens Pharmacist Recommeneded
    Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Simply Sleep®

    50844      REV1019A62712

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED
    walgreens.com    ©2018 Walgreen Co.

    44-627

    44-627

  • INGREDIENTS AND APPEARANCE
    DYE FREE SLEEP AID 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6270
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;627
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6270-121 in 1 CARTON12/01/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33812/01/2018
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(0363-6270) , PACK(0363-6270)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-6270)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0363-6270)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-6270)
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