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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 17, 2017

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  • Active Ingredient

    Diphenhydramine HCl, 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    relieves occasional sleeplessness

  • Warnings

    Do not use

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    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

    When using this product

    • avoid alcoholic beverages
    • be careful when driving a moter vehicle or operating machinery

    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, gret 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
    • children under 12 years: do not use
  • Other information

    • each caplot contains: calcium 12 mg
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    crosscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, tracetin

  • PRINCIPAL DISPLAY PANEL

    Nytol QuickCaps with Diphenhydramine HCl

    Nighttime Sleep-Aid

    32 caplets

    Nytol QuickCaps 32 count carton

  • PRINCIPAL DISPLAY PANEL

    Nytol QuickCaps with Diphenhydramine HCl

    Nighttime Sleep-Aid

    16 caplets

    Nytol QuickCaps 16 count carton

  • 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)  
    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 BOX01/16/2013
    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 finalpart33806/01/2012
    Labeler - Medtech Products Inc. (122715688)
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