Label: VICKS ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

  • NDC Code(s): 69423-812-12, 69423-812-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • When using this product

    • avoid alcoholic beverages
  • STOP USE

    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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • Directions

    • take only one dose (30 mL) per day (24 hours)
    • only use the dose cup provided
    adults & children 12 yrs & over30 mL at bedtime if needed or as directed by a doctor
    children under 12 yrsdo not use

  • Other information

    • each 30 mL dose cup contains: sodium 22 mg
    • store at no greater than 25°C
  • Inactive ingredients

    alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing

  • SPL UNCLASSIFIED SECTION

    DIST. BY

    PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL

    VICKS ®

    ZzzQuil™

    NIGHTTIME SLEEP-AID

    Diphenhydramine HCl

    Fall Asleep Fast

    Non-Habit Forming

    Calming Vanilla Cherry

    Not for colds or for pain
    Alcohol 10%

    12 FL OZ (354 mL)

    812

  • INGREDIENTS AND APPEARANCE
    VICKS ZZZQUIL  NIGHTTIME SLEEP-AID
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-812
    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
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorVANILLA, CHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-812-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2021
    2NDC:69423-812-242 in 1 CARTON10/11/2021
    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 DrugM01002/03/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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