Label: NYTOL- diphenhydramine hcl tablet

  • NDC Code(s): 63029-211-01, 63029-211-02
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each caplet)

    Diphenhydramine HCI 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    For relief of occasional sleeplessness.

  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    a breathing problem such as emphysema or chronic bronchitis

    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 continuously for more than 2 weeks. Insomnia may be a symptom of 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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years of age and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • Other information

    • each caplet contains: calcium 12 mg
    • store below 25ºC (77ºF)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin, water

  • Questions? 

    1-866-255-5203

    TAMPER EVIDENT FEATURE:

    This product is protected in a sealed blister. Do not use if blister or printed foil is broken or torn.

  • PRINCIPAL DISPLAY PANEL

    Nytol® QUICKCAPS®
    with Diphenhydramine HCl
    NIGHTTIME SLEEP-AID
    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
    16 CAPLETS

    PRINCIPAL DISPLAY PANEL Nytol® QUICKCAPS® with Diphenhydramine HCl NIGHTTIME SLEEP-AID THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 16 CAPLETS

  • INGREDIENTS AND APPEARANCE
    NYTOL 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-211
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-211-014 in 1 BOX06/01/2012
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-211-022 in 1 BOX06/01/2012
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/01/2012
    Labeler - Medtech Products Inc. (122715688)
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