Label: VICKS ZZZQUIL NIGHT PAIN- diphenhydramine hydrochloride and acetaminophen tablet, coated

  • NDC Code(s): 37000-974-60
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each geltab)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 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

    • adult takes more than 4 doses (2 geltabs each) in 24 hrs, which is the maximum daily amount for this product

    • taken 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

    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 DOCTOR

    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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

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

    When using this product

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

    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.

  • 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. 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 2 geltabs per day (24 hours)

    adults & children 12 yrs & over2 geltabs at bedtime
    children under 12 yrsdo not use

  • Other information

    • store at no greater than 25° C
  • Inactive ingredients

    corn starch, croscarmellose sodium, D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1, FD&C Blue No. 1 Aluminum Lake, gelatin, glycerin, hypromellose, iron oxide black, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, silicon dioxide, stearic acid, titanium dioxide

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed safety seal under cap is broken or missing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 60 GelTab Carton

    VICKS ®

    ZzzQuil
    NIGHT PAIN
    NIGHTTIME SLEEP-AID

    PAIN RELIEVER
    Diphenhydramine HCl

    Acetaminophen

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

    Not for colds.

    60 GelTabs

    974

  • INGREDIENTS AND APPEARANCE
    VICKS ZZZQUIL  NIGHT PAIN
    diphenhydramine hydrochloride and acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-974
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpurple (and white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code Zzz
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-974-601 in 1 CARTON06/01/2020
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/01/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Supriya Lifesciences, Ltd.650542744api manufacture(37000-974)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918610754api manufacture(37000-974)