EZ NITE SLEEP (ZZZQUIL) LIQUID [P & L DEVELOPMENT, LLC]

EZ NITE SLEEP (ZZZQUIL) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0242-2
Set ID 9a380c04-6e54-4746-9dd3-29c4001f2707
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    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

  • Do Not Use

    for children under 12 years of age

    with any other product containing diphenhydramine, even one used on the skin

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

    do not use with Nyquil

  • Ask a doctor before use if you have

    • glaucoma

    heart disease
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or
    chronic bronchitis

  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep-aid

  • When using this product

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

  • Keep this and all drugs out of the reach of children.

    Overdose warning: taking more than the recommended dose (overdose) may cause serious health problems. In case of overdose, get medical help or contact Poison Control CEnter 1-800-222-1222 immediately.

  • Directions

    • take only one dose per day (24 hours)
    • use dosage cup provided
    • tbsp=tablespoon, mL=milliliter

    agedose
    adults and children 12 years and over      one dose = 2 tablespoons, 30mL at bedtime if needed or as directed by a doctor

  • Other information

    • each 30mL 2tbsp contains: sodium 23 mg
    • store at controlled room temperature

    protect from light

  • Inactive ingredients

    citric acid, ethyl alcohol, fd and c blue 1, fd and c red 40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate

  • Principal Display Panel

    EZ nite sleep nighttime sleep aid

    Berry

    Diphenhydramine HCI

    non habit forming

    not for treating cold or flu

    alcohol 10 percent

    compare to active igredient in Vicks Zzzquil

    12 fl oz 355mL

    image of label
  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    zzzquil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0242
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (Berry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0242-2355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201312/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/201312/30/2021
    Labeler - P & L Development, LLC (101896231)

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