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

EZ NITE SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [THE KROGER CO.]
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NDC 30142-229-24
Set ID 876eeb7c-75b8-8124-e053-2995a90ae922
Category HUMAN OTC DRUG LABEL
Packager THE KROGER CO.
Generic Name
Product Class
Product Number
Application Number PART338
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT (in each softgel)

    Diphenhydramine HCl 25mg

  • Purpose

    Nighttime sleep-aid

  • Uses

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

    Drug Facts (continued)

  • WARNINGS

    Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin.
  • Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are  taking sedatives or tranquilizers 

  • WHEN USING

    When using this product 

    • avoid alcoholic beverages
  • STOP USE

    Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take only one dose per day (24 hours)
     adults & children 12 years & over    One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
     children under 12 years    Do not use

  • Other information

    • Store at 20-25° C (68-77° F)
    • avoid excessive heat above 40° C (104° F)
    • Protect from light
  • Inactive ingredients 

    FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • QUESTIONS

    Questions or comments? 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO the active ingredient of ZZZQUIL® *see side panel

    NDC 30142-229-24

    Kroger®

    Nighttime Sleep-Aid

    EZ Nite Sleep

    Diphenhydramine HCL 25 mg

    Helps Reduce Difficulty Faling Asleep

    actual size

    Non-Habit Forming

    Not fro Treating Cold or Flu- See Warnings

    24 SOFTGELS

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

    SLEEP AID

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-229
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 602
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-229-242 in 1 CARTON04/25/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/25/2019
    Labeler - THE KROGER CO. (006999528)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(30142-229)

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