NYTOL (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]

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NYTOL (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]
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NDC 63029-211-01, 63029-211-02
Set ID c81d018a-0170-4396-81e9-2e13a53f868a
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART338
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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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