Label: ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride solution

  • NDC Code(s): 37000-430-12, 37000-430-24
  • 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 January 8, 2020

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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 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    • take only one dose per day (24 hours)
    • only use the dose cup provided
    adults & children 12 yrs & over30 mL at bed time if needed or as directed by a doctor
    children under 12 yrsdo not use
  • Other information

    • each 30 mL contains: sodium 24 mg
    • store at controlled room temperature
  • 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

  • Questions or comments?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202.

  • PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

    NEW

    FLAVOR

    From the makers of VICKS ® NyQuil™

    ZzzQuil™

    NIGHTTIME SLEEP-AID

    Diphenhydramine HCl

    Non-Habit Forming

    Calming Vanilla Cherry

    Not for treating Cold or Flu

    Alcohol 10%

    12 FL OZ (354 ml)

    430 NEW

  • INGREDIENTS AND APPEARANCE
    ZZZQUIL  NIGHTTIME SLEEP-AID
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-430
    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
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorVANILLA, CHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-430-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2015
    2NDC:37000-430-242 in 1 CELLO PACK02/03/2015
    2354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33802/03/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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