Label: VICKS ZZZQUIL ULTRA- doxylamine succinate tablet

  • NDC Code(s): 69423-902-01, 69423-902-12, 69423-902-24, 69423-902-32, view more
    69423-902-48
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    • helps to reduce difficulty in falling asleep
  • Warnings

    Do not use in children under 12 years of age

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking any other drugs

    When using this product

    • avoid alcoholic beverages
    • take only at bedtime

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than two 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.In case of overdose, get medical help or contact a Poison Control Center right away.

    (1-800-222-1222)

  • Directions

    adults & children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor

    children under 12 years of age: do not use

  • Other information

    • store at 68-77° F (20°-25° C)
    • retain carton until time of use
    • see carton end panel for lot number and expiration date
  • Inactive ingredients

    anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate,
    microcrystalline cellulose, sodium starch glycolate

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    Tamper Evident:Do not use if blister is opened or torn. If difficult to open, use scissors.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE

    CINCINNATI OH 45202.

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

    NEW active ingredient.

    NEW directions.

    Read label.

    VICKS ®

    ZzzQuil™
    ULTRA
    NIGHTTIME SLEEP-AID
    Doxylamine succinate tablets, 25 mg nighttime sleep-aid

    24 TABLETS

    From the makers of NyQuil

    Clinically tested, proven effective

    actual size

    1 TABLET

    PER DOSE

    zqultra

  • INGREDIENTS AND APPEARANCE
    VICKS ZZZQUIL  ULTRA
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code L441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-902-121 in 1 CARTON03/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69423-902-242 in 1 CARTON03/01/2021
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69423-902-484 in 1 CARTON03/01/2021
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:69423-902-011 in 1 POUCH; Type 0: Not a Combination Product10/16/2023
    5NDC:69423-902-3232 in 1 CARTON10/16/2023
    51 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04016703/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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