Label: NIGHTTIME SLEEP AID BERRY FLAVOR- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 19, 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 emphysema, or chronic bronchitis
    ▪
    glaucoma
    ▪
    difficulty in urination due to enlargement of the 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 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:

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

  • Directions

    ▪
    take only one dose per day (24 hours)
    ▪
    only use cup provided.

    adults & children 12yrs & 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 contains: potassium 5 mg, sodium 10 mg
    ▪
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    NDC 67091-630-06

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

    Nighttime Sleep-Aid

    Diphenhydramine HCl

    Non-Habit Forming

    Makes you fall asleep fast

    BERRY FLAVOR

    Naturally and Artificially Flavored

    No added alcohol

    Not for Pain. Not for Colds.

    Just for Sleep

    6 FL OZ (177 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

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

    WINCO Sleep Aid Nighttime Berry Flavor
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID  BERRY FLAVOR
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-630
    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
    FlavorBERRY (Naturally and Artificially) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-630-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/09/2023
    Labeler - WINCO FOODS, LLC (056098817)
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