Label: SLEEP II NIGHTTIME SLEEP AID- diphenhydramine hcl tablet

  • NDC Code(s): 0363-0189-08, 0363-0189-21, 0363-0189-23, 0363-0189-46
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2023

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  • Active ingredient (in each tablet)

    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

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

    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 tablets at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each tablet contains: calcium 60 mg
    • protect from moisture
    • 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

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

    WALGREENS PHARMACIST RECOMMENDED†

    Compare to the active ingredient
    in Original Formula Sominex®††

    NDC 0363-0189-46

    NIGHTTIME SLEEP AID
    Sleep II
    DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

    Nighttime

    96 TABLETS

    ACTUAL SIZE

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

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2021 Walgreen Co.

    50844    ORG101918946

    †Our pharmacists recommend the Walgreens brand.
    We invite you to compare to national brands.
    ††This product is not manufactured or distributed by
    Medtech Products Inc., owner of the registered
    trademark Original Formula Sominex®.

    Walgreens 44-189

    Walgreens 44-189

  • INGREDIENTS AND APPEARANCE
    SLEEP II  NIGHTTIME SLEEP AID
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0189
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;189
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0189-461 in 1 CARTON04/10/1990
    196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0189-212 in 1 CARTON04/10/199007/08/2018
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0189-083 in 1 CARTON04/10/199008/14/2022
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0363-0189-231 in 1 CARTON04/10/199002/13/2022
    472 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/10/1990
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-0189) , pack(0363-0189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(0363-0189)
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