Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl tablet

  • NDC Code(s): 57896-785-72
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Active ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25mg

  • Purpose

    Nighttime Sleep-aid

  • Uses

    • relieves occasional sleeplessness
  • Warnings

    Do not use

    • in children under 12 years of age

    • 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 product

    • 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.

  • 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

  • Other information

    • each caplet contains: calcium 85mg
    • store at 20°C-25°C (68°F-77°F)
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Inactive ingredients

    calcium phosphate, croscarmellose sodium, magnesium stearate,

    microcrystalline cellulose, silica.

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-785
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 93XF;57344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-785-7272 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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