Label: VICKS ZZZQUIL NIGHT PAIN- diphenhydramine hydrochloride and acetaminophen liquid

  • NDC Code(s): 69423-985-02, 69423-985-12
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 16, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 1000 mg

    Diphenhydramine HCl 50 mg

  • Purpose

    Pain reliever

    Nighttime sleep-aid

  • Uses

    • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
  • Warnings

    Liver warning: This product contains acetaminophen. Severe

    liver damage may occur if you take

    • more than 4 doses (30 mL each) in 24 hours, which is the maimum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert: Acetaminophen may cause severe skin reactions.

    Symptoms may include: • skin reddening • blisters • rash

    If a skin reaction occurs, stop use and seek medical help right away

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic beverages
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • sleeplessness persists continuously for more than 2 weeks.

    Insomnia may be a symptom of serious underlying medical illness.

    These could be signs of a serious condition.

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only one dose (30 mL) per day (24 hours)
    • only use the dose cup provided
     adults & children 12 yrs & over 30 mL at bedtime
     children under 12 yrs do not use

  • Other information

    • each 30 mL contains:sodium 93 mg
    • store at no greater than 25° C and do not refrigerate
  • Inactive ingredients

    alcohol, citric acid, FD&C Red No. 40, flavors, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum.

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKWRAP SEAL AROUND NECKBAND IS BROKEN OR MISSING.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 354 ml bottle

    VICKS ®

    ZzzQuil

    NIGHT PAIN

    NIGHTTIME SLEEP-AID

    PAIN RELIEVER

    Diphenhydramine HCl

    Acetaminophen

    • Fall Asleep Fast
    • Max Strength Pain Reliever
    • Non-Habit Forming

    Black Cherry

    Not For Colds

    Alcohol 10%

    12 FL OZ (354 ml)

    985

  • INGREDIENTS AND APPEARANCE
    VICKS ZZZQUIL  NIGHT PAIN
    diphenhydramine hydrochloride and acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-985
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-985-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2023
    2NDC:69423-985-022 in 1 CARTON03/03/2023
    2354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/03/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hood Container Corporation129850751pack(69423-985)