Label: ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, gelatin coated

  • NDC Code(s): 37000-501-02, 37000-501-08, 37000-501-12, 37000-501-24, view more
    37000-501-48, 37000-501-72, 37000-501-96
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each liquicap)

    Diphenhydramine HCl 25 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 DOCTOR

    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

    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 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 (2 LiquiCaps) per day (24 hours)

    adults & children 12 yrs & over2 LiquiCaps at bedtime if needed or as directed by a doctor
    children under 12 yrsdo not use

  • Other information

    • store at no greater than 25°C (77°F)
    • avoid excessive heat above 40°C (104°F)

    • protect from light

  • Inactive ingredients

     FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, shellac*, sorbitan, sorbitol, titanium dioxide*, water
    *May contain these ingredients

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    Tamper Evident: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA.

    DIST. BY: PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 12 LiquiCap Carton

    VICKS ®

    ZzzQuil™

    NIGHTTIME SLEEP-AID
    Diphenhydramine HCl

    Not for colds or for pain

    Fall Asleep Fast

    Non-Habit Forming

    12 LIQUICAPS™

    501

  • INGREDIENTS AND APPEARANCE
    ZZZQUIL  NIGHTTIME SLEEP-AID
    diphenhydramine hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MANNITOL (UNII: 3OWL53L36A)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code Zzz
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-501-126 in 1 CARTON12/08/2011
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:37000-501-2412 in 1 CARTON12/08/2011
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:37000-501-4824 in 1 CARTON12/08/2011
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:37000-501-7236 in 1 CARTON12/08/2011
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:37000-501-962 in 1 CELLO PACK01/01/2020
    524 in 1 CARTON
    52 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:37000-501-088 in 1 CARTON06/07/2022
    62 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:37000-501-022 in 1 BLISTER PACK; Type 0: Not a Combination Product08/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01012/08/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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