EZ NITE SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [THE KROGER CO.]

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EZ NITE SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [THE KROGER CO.]
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NDC 30142-114-12, 30142-114-24
Set ID 8572013c-0a1b-4b56-9ac8-61e80491ca6d
Category HUMAN OTC DRUG LABEL
Packager The Kroger Co.
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

    edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitan, sorbitol

    *may contain this ingredient

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredient of ZZZQUIL®  *See bottom panel

    EZ Nite Sleep

    Diphenhydramine HCl, 25 mg

    Nighttime Sleep-Aid

    Non-Habit Forming

    Not for Treating Cold or Flu

    See Warnings

    SOFTGELS

    *ZZZQUIL® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with The Kroger Co. or this product.

    Product of Canada

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202

    www.kroger.com

    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

    Kroger EZ Nite Sleep Softgels

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-114
    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 GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code A41;602
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-114-1212 in 1 CARTON12/31/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:30142-114-2424 in 1 CARTON12/31/2014
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33812/31/2014
    Labeler - The Kroger Co. (006999528)
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