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

  • NDC Code(s): 37000-501-12, 37000-501-24, 37000-501-48, 37000-501-72
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 21, 2018

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

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

    When using this product

    • avoid alcoholic beverages

    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.

    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.

  • Directions

    • take only one dose per day (24 hours) - see Overdose warning

    adults & children 12 yrs & over

    One dose = TWO 25 mg LiquiCaps (50 mg) at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use

  • Other information

    • store at 20-25° C (68-77° 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, pharmaceutical ink*, polyethylene glycol, purified water, sorbitol sorbitan solution.
    *May contain this ingredient.

  • Questions?

    1-877-881-5813

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati OH 45202.

  • PRINCIPAL DISPLAY PANEL - 12 Capsule Carton

    NEW From the makers of VICKS ® NyQuil ®

    ZzzQuil

    NIGHTTIME SLEEP-AID

    Diphenhydramine HCl

    Non-Habit Forming

    See Warnings

    Not for treating Cold or Flu

    12 LiquiCaps

    501 New

  • 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 HYDROCHLORIDE50 mg  in 2 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33812/08/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)