EZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]

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  • EZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]

EZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]
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NDC 55319-404-12
Set ID 6252569a-c738-4031-9b5b-87c8d5e95ce8
Category HUMAN OTC DRUG LABEL
Packager Family Dollar (FAMILY WELLNESS)
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

    Ask a doctor before use if you have

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

    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 a serious underlying medical illness.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • take only one dose (2 softgels) per day (24 hours)
    • swallow whole; do not crush, chew, or dissolve
    • adults & children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
    • children under 12 years of age: do not use
  • Other information

    • store between 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?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN ZZZQUIL®†

    NIGHTTIME SLEEP-AID

    EZ Nite Sleep

    Diphenhydramine HCl, 25 mg

    Non Habit-Forming

    Not for Treating Cold or Flu

    See Warnings

    SOFTGELS**

    (**LIQUID-FILLED CAPSULES)

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS, NC 28105

    †This product is not manufactured or distributed by The Procter & Gamble Company.  ZZZQUIL® is a registered trademarks of The Proctor & Gamble Company.

    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 HCI 25 mg

    FAMILY WELLNESS EZ Nite Sleep

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP  NIGHTTIME SLEEP AID
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-404
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    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:55319-404-1212 in 1 BOX07/31/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33807/31/2014
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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