Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl 25 mg capsule

  • NDC Code(s): 21130-004-12, 21130-004-24, 21130-004-48
  • Packager: Safeway, 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 November 19, 2020

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

  • Active ingredient (in each softgel)

     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 other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged 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 right away.

  • Directions

    • take only one dose (2 softgels) per day (24 hours) 
    • swallow whole; do not crush, chew, or dissolve
    • adults and children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
    • children under 12 years of age: do not use
  • Other information

    •  store between 20-25ºC (68-77ºF)
    • avoid excessive heat above 40ºC (104ºF) and high humidity
    • protect from light
  • Inactive ingredients

     edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitan, sorbitol

    *may contain this ingredient

  • Questions or comments?

     Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    COMPARE TO ZZZQUIL® active ingredient†

    Nighttime Sleep-Aid

    DIPHENHYDRAMINE HCl 25 mg

    • Non-habit forming
    • Not for treating cold or flu

    SOFTGELS

    Failure to follow these warnings could result in serious consequences

    †This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

    P.O. BOX 99

    PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

    Product of India

  • Package Label

    Diphenhydramine HCI 25 mg

    SIGNATURE CARE Nighttime Sleep Aid

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl 25 mg capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-004
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code A41;602
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-004-2424 in 1 CARTON12/31/201412/30/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-004-1212 in 1 CARTON12/31/201412/30/2022
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:21130-004-4848 in 1 CARTON12/31/201412/30/2022
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33812/31/201412/30/2022
    Labeler - Safeway, Inc. (009137209)