Label: NIGHTTIME SLEEP EASY- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 59726-400-12
  • Packager: P and L Development of New York Corporation (ReadyInCase)
  • 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 04/14

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

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

    Purpose

    Nighttime sleep-aid

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  • Uses

    provides relief of occasional sleeplessness

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  • Warnings

    Do not use

    •  with any other products containing diphenhydramine, even one used on skin
    • in children under 12 years of age

    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

    • drowsiness will occur
    • avoid alcoholic drinks
    • 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.

    Overdose Warning: In the case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Do not take more than directed

    • adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
    • children under 12 years of age: do not use
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  • Other information

    • each caplet contains: calcium 25 mg
    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • avoid excessive heat and humidity
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  • Inactive ingredients

    carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

    *contains one or more of these ingredients

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
     

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  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Tylenol® Simply Sleep®†

    readyincase™

    nighttime

    sleep-aid

    diphenhydramine HCl 25 mg

    non-habit forming

    fall asleep fast wake up rested

    does not contain pain reliever

    caplets

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

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

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  • Product Labeling

    Diphenhydramine HCl 25 mg

    Readyincase Nighttime Sleep-aid

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP EASY 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59726-400
    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  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE (blue) Score no score
    Shape CAPSULE Size 11mm
    Flavor Imprint Code T129;S25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-400-12 12 in 1 BOX
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 12/04/2012
    Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)
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