Label: SLEEP-AID- diphenhydramine hydrochloride tablet

  • NDC Code(s): 55301-189-23
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/15

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    helps to reduce difficulty falling asleep

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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 an 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
    • 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

    • 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
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  • Other information

    • each tablet contains: calcium 60 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    exchange √ select

    Compare to The Active Ingredient of
    Original Formula Sominex®*

    Sleep Aid
    DIPHENHYDRAMINE HCl 25 mg
    Nighttime Sleep-Aid

    Wake Up Rested and Refreshed
    Doctor Preferred Sleep Ingredient

    Actual Size

    72 TABLETS

    quality value

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®.
    50844        REV1014H18923

    "SATISFACTION GUARANTEED OR YOUR MONEY BACK"
    Manufactured For Your Military Exchanges
    Distributed by: LNK International, Inc.
    Hauppauge, NY 11788
    1-800-426-9391

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Exchange Select 44-189

    Exchange Select 44-189

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  • INGREDIENTS AND APPEARANCE
    SLEEP-AID 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-189
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;189
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-189-23 9 in 1 CARTON
    1 8 in 1 BLISTER PACK; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 12/25/1992
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55301-189)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55301-189)
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