WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [WALGREEN COMPANY]

WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [WALGREEN COMPANY]
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NDC 0363-0060-24
Set ID cfb67ead-61f9-4d0f-b2db-792b8df3d148
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART338
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each liquicap)

    Diphenhydramine HCl 25 mg

  • Purpose

    nighttime sleep-aid

  • Uses

    • for the 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
    • be careful 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 serious underlying medical illness.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    adults & children
    12 yrs & over
    One dose = TWO 25 mg Softgels (50 mg)
    at bed time if needed or as directed by a doctor
  • Other information

    • store at 20-25° C (68-77° F)
    • avoid excessive heat above 40° C (104° F) and high humidity
    • Protect from light
  • Inactive ingredients

    FD&C blue 1, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

    TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.

    Distributed by: Walgreen Co.

    200 Wilmot Rd., Deerfield, IL 60015

  • PRINCIPAL DISPLAY PANEL

    Wal-Sleep Z™
    Diphenhydramine HCl / Sleep Aid

    Well at Walgreens

    Walgreens Pharmacist Recommended

    Non-Habit Forming

    Alcohol Free

    NIGHTTIME

    Not for treating Cold or Flu

    Compare to ZzzQuil® Liquicaps® active ingredient‡‡

    24 SOFTGELS

    Wal-Sleep Z 24 Softgels
  • INGREDIENTS AND APPEARANCE
    WAL-SLEEP Z  DIPHENHYDRAMINE HCL / SLEEP AID
    diphenhydramine hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg  in 2 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code R060
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0060-2424 in 1 CARTON
    12 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33812/08/2011
    Labeler - Walgreen Company (008965063)

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