Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 66715-6743-8
  • Packager: Lil' Drug Store Products, Inc.
  • 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 April 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each liquid-filled capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 a 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 (1-800-222-1222) right away.

  • Directions

    • do not take more than directed
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive heat above 40°C (104°F) and high humidity
    • see end flap for expiration date and lot number
    • protect from light
  • Inactive ingredients

    edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

  • Questions?

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

    QUALITY
    GUARANTEED

    *Compare to the Active Ingredient in VICKS ®
    ZzzQuil ® NIGHTTIME SLEEP-AID LiquiCaps ®

    Nighttime
    Sleep-Aid

    Diphenhydramine HCl 25 mg
    Sleep-Aid

    • Non-Habit Forming

    ACTUAL SIZE

    Not for treating Cold or Flu

    24
    Softgels

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6743
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 654
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6743-82 in 1 CARTON07/15/201901/07/2025
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33807/15/201901/07/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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