ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-500-06, 37000-500-12, 37000-500-24, 37000-500-36
Set ID e441c952-cd48-4159-ada2-271ca7541600
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number PART338
  • 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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