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 06/13

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 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
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic drinks

    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.

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  • Directions

    • adults and children 12 years and older; 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

    • see end flap for expiration date and lot number
    • store at controlled room temperature 15º-30ºC (59º-86ºF)
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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 selectâ„¢

    Compare to The Active Ingredient of Sominex®*

    SLEEP AID
    DIPHENHYDRAMINE HCl 25 mg
    NIGHTTIME SLEEP-AID

    Wake Up Rested and Refreshed
    Doctor preferred sleep ingredient

    72 TABLETS

    *This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Sominex®.
    50844        REV010E18923

    SATISFACTION GUARANTEED OR YOUR MONEY BACK
    Manufactured For: Your Military Exchanges
    by: LNK International, Inc.
    Hauppauge, NY 11788

    TAMPER EVIDENT: DO NOT USE IF CARTON 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 2 pieces
    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 1 in 1 CARTON
    1 72 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 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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