EZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • EZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

EZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
PDF | XML
NDC 63868-014-24, 63868-014-48
Set ID f85f73a2-9300-4b9b-89ab-f0d389d79c3c
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • for children under 12 years of age
    • with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • heart disease
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep-aid.

    When using this product

    • drowsiness will occur
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • be careful when driving a motor 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 a serious underlying medical illness.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    • swallow whole; do not crush, chew, or dissolve
    • adults & children 12 yrs & over
      • one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F) and high humidity
    • protect from light
  • Inactive ingredients

    FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in ZZZQUIL®

    EZ Nite Sleep

    Nighttime Sleep-Aid

    Diphenhydramine HCl 25 mg

    Non Habit-Forming

    Not for Treating Cold or Flu | See Warnings

    Softgels**

    (**Liquid-filled capsules)

    *This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company. 

    ©Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Product of Canada

    Failure to follow these warnings could result in serious consequences.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

  • Product Label

    Diphenhydramine HCl 25 mg

    Quality Choice EZ Sleep Softgel

     
  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP  NIGHTTIME SLEEP-AID
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-014
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code A41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-014-484 in 1 CARTON
    112 in 1 BLISTER PACK
    2NDC:63868-014-242 in 1 CARTON
    212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33803/11/2013
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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