Label: SLEEP AID DYE-FREE NIGHTTIME- diphenhydramine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 31, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    for relief of occasional sleeplessness

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  • Warnings

    Do not use

    • in 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

    • drowsiness will occur
    • avoid alcoholic beverages
    • do not drive a motor vehicle or operate 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. 

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  • 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
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  • Other information

    • each caplet contains: calcium 28 mg 
    • see end flap for expiration date and lot number
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    NDC 0363-0627-12

    DYE-FREE • NIGHTTIME
    Sleep Aid

    Diphenhydramine HCl 25 mg / 
    Nighttime Sleep Aid

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

    100
    MINI-CAPLETS

    Actual Size

    DYE-FREE

    NIGHTTIME

    Compare to Simply Sleep®
    active ingredient⧧⧧

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

    ⧧Walgreens Pharmacist Survey Study,
       November 2014.

    ⧧⧧This product is not manufactured
        or distributed by McNeil Consumer
        Healthcare, owner of the registered
        trademark Simply Sleep®.
        50844        REV0915A62712

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    Walgreens
    100% SATISFACTION GUARANTEED
    walgreens.com    ©2016 Walgreen Co.

    Walgreens 44-627

    Walgreens 44-627



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  • INGREDIENTS AND APPEARANCE
    SLEEP AID  DYE-FREE NIGHTTIME
    diphenhydramine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0627
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOLS (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)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code 44;627
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0627-12 1 in 1 CARTON 07/01/2013
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 07/01/2013
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-0627)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-0627)
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