Label: PREMIER VALUE NIGHTTIME SLEEP-AID LIQUID SLEEP-AID- diphenhydramine hydrochloride liquid

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

Drug Label Information

Updated November 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 30 mL dose cup or 2 tablespoons)

    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
    •
    with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    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
    •
    heart disease

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

    When using this product

    •
    avoid alcoholic beverages and other drugs that cause drowsiness
    •
    drowsiness will occur
    •
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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.

  • Directions

    •
    take only one dose per day (24 hours) - see Overdose warning
    •
    use dose cup or tablespoon

    adults & children 12 yrs & over

    One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
  • Other information

    •
    each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    •
    store at room temperature
    •
    protect from light. Does not meet USP <671>.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Failure to follow these warnings could result in serious consequences

    TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

    This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™.

    Distributed by:

    Chain Drug Consortium LLC.

    3301 N.W. Boca Raton Blvd.

    Suite 101, Boca Raton FL 33431

  • PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

    Premier Value
    Nighttime

    Sleep-Aid

    Diphenhydramine HCl /

    •
    Non-Habit Forming

    Berry Flavor

    Not for treating Cold or Flu
    See Warnings

    12 FL OZ (354 ml)

    Premier Value Nighttime Sleep Aid
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE NIGHTTIME SLEEP-AID LIQUID  SLEEP-AID
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-219
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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:68016-219-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/10/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01012/10/2012
    Labeler - Chain Drug Consortium (101668460)
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