Label: KROGER NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL dose cup)

    Diphenhydramine HCl 50 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

    • 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 asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

    When using this product

    • avoid alcoholic beverages

    Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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.1-800-222-1222

  • Directions

    • take only one dose per day (24 hours)
    • Only use dose cup provided

    adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    Children under 12 yrs

    Do not use
  • Other information

    • each 30 mL dose cup contains: potassium 5 mg; sodium 10 mg
    • store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

    NDC 41226-730-12

    Nighttime

    Sleep-Aid

    Diphenhydramine HCl

    • Non-habit forming
    • Makes you fall asleep fast

    Berry Flavor

    Naturally & artificially flavored

    No added alcohol

    Not for pain. Not for Colds.

    Just for Sleep

    12 FL. OZ. (354 mL)

    TAMPER EVIDENT:Do not use if printed shrink band is missing or broken

    *This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    Distributed by:

    KROGER Nighttime Sleep Aid Berry Flavor 12 FL OZ
  • INGREDIENTS AND APPEARANCE
    KROGER NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-730
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-730-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/27/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01005/27/2024
    Labeler - KROGER COMPANY (006999528)
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