Label: EZ NITE SLEEP NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 55319-404-12
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 October 20, 2021

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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 BOX07/31/201404/26/2024
    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 finalpart33807/31/201404/26/2024
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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