Label: ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

  • NDC Code(s): 37000-500-06, 37000-500-12, 37000-500-24, 37000-500-36
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 10, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Diphenhydramine HCl 50 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

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

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    • 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

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  • Other information

    • each 30 mL dose (2 tablespoons) contains: sodium 24 mg
    • store at controlled room temperature
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  • Inactive ingredients

    alcohol, citric acid anhydrous, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

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  • Questions?

    1-877-881-5813

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202.

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  • PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

    NEW From the makers of VICKS ® NyQuil®

    ZzzQuil

    NIGHTTIME SLEEP-AID

    Diphenhydramine HCl

    • Non-Habit Forming
    • Warming Berry Flavor

    Not for treating Cold or Flu

    See Warnings

    Alcohol 10%

    12 FL OZ (354 ml)

    500 New

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  • INGREDIENTS AND APPEARANCE
    ZZZQUIL  NIGHTTIME SLEEP-AID
    diphenhydramine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-500
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color purple Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-500-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2011
    2 NDC:37000-500-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2011
    3 NDC:37000-500-24 2 in 1 PACKAGE, COMBINATION 12/08/2011
    3 NDC:37000-500-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4 NDC:37000-500-36 3 in 1 PACKAGE, COMBINATION 12/08/2011
    4 NDC:37000-500-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 12/08/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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