Label: SLEEP ORIGINAL FORMULA- diphenhydramine hydrochloride tablet

  • NDC Code(s): 63941-200-16
  • Packager: Best Choice (Valu Merchandisers Company)
  • 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 11/12

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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  • Use

    helps reduce difficulty falling asleep

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  • Warnings

    Do not give to children under 12 years of age.

    Do not use this product

    with other products containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • emphysema

    • chronic bronchitis

    • glaucoma

    • 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.

    stop use and ask a doctor if

    • sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    If pregnant or breast-feeding,

    ask a health care 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 over: take 2 tablets at bedtime if needed or as directed by a doctor. For best results, take recommended dose.
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  • Other information

    • each tablet contains: calcium 65 mg
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • avoid excessive heat and humidity
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  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate and microcrystalline cellulose

    May also contain: silicon dioxide and stearic acid

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  • Principal Display Panel

    Compare to the active ingredient in Sominex®*

    *This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

    SLEEP TABLETS

    wake rested and refreshed

    Nighttime Sleep-Aid

    Diphenhydramine HCl 25 mg

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    KANSAS CITY, MO 64111

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

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  • Product Label

    best choice valu merchandisers

    Nighttime sleep-aid

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  • INGREDIENTS AND APPEARANCE
    SLEEP  ORIGINAL FORMULA
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63941-200
    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  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SILICON DIOXIDE  
    FD&C BLUE NO. 1  
    STEARIC ACID  
    ALUMINUM OXIDE  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code 1008;1008
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63941-200-16 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 07/16/2010
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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