Label: NIGHTTIME SLEEP-AID - diphenhydramine hydrochloride tablet 

  • NDC Code(s): 57896-785-72
  • Packager: Geri-Care Pharmaceutical Corp
  • 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 12/13

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

  • Active ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25mg

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  • Purpose

    Nighttime Sleep-aid

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  • Uses

    • relieves occasional sleeplessness
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  • Warnings

    Do not use

    • in children under 12 years

    • with any other product containing diphenhydramine, including one used

    on skin


    Ask a doctor before use if you have

    • a breathing problem such as emphysema, asthma, or chronic bronchitis

    • glaucoma

    • 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 produc
    t

    • avoid alcoholic beverages

    • drowsiness will occur

    • avoid driving a motor vehicle or operating machinery


    Stop use and ask a doctor if
    • sleeplessness persists continuously for more than two 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.

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  • Directions

    • adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

    • do not exceed recommended dose

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  • Other information

    • each caplet contains: calcium 85mg
    • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
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  • Inactive ingredients

    calcium phosphate, croscarmellose sodium, magnesium stearate,

    microcrystalline cellulose, silica.

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  • package label

    NDC 57896-785-72

    Health Star

    the sensible choice for price and health


    NightTime Sleep-Aid

    with Diphenhydramine HCl


    72 Caplets

    25 mg each

    Compare to active ingredient in Nytol

    Night time sleep aid label

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-785
    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
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CELLULOSE, MICROCRYSTALLINE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 93XF;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-785-72 72 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 01/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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