Label: SLEEP AID- diphenhydramine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 59779-431-62, 59779-431-78
  • Packager: CVS Pharmacy
  • 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 03/12

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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  • Uses

    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

    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    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 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. (1-800-222-1222)

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  • Directions

    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 15 mg
    • store at 20-25°C (68-77°F)
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  • Inactive ingredients

    carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient in Simply Sleep®

    Nighttime

    SLEEP-AID

    MINI-CAPLETS

    DIPHENHYDRAMINE HCl 25 mg

    For a restful night's sleep

    Safe, non-habit forming

    Does not contain pain reliever

    Sleep-Aid Carton Image 1

    Sleep-Aid Carton Image 1

    Sleep-Aid Carton Image 2

    Sleep-Aid Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-431
    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
    CARNAUBA WAX  
    CROSPOVIDONE  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE (Light Blue) Score no score
    Shape CAPSULE Size 11mm
    Flavor Imprint Code L431
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-431-62 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:59779-431-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 10/03/2000
    Labeler - CVS Pharmacy (062312574)
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