Label: SLEEP-AID DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 70000-0584-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • Drug Facts

  • Active ingredient (in each softgel)

    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 •with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid

    When using this product •avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

    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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    •take only one dose per day (24 hours)

     adults and children
    12 years and over    		 take 2 softgels at bedtime if needed
    or as directed by a doctor
     children under 12 years 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

    edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-888-577-8033 Monday-Friday 8am-4pm EST

  • SPL UNCLASSIFIED SECTION

    LEADER ™

    Non-Habit Forming

    Not for Treating Pain, Cold or Flu

    COMPARE TO VICKS® ZZZQUIL® NIGHTTIME SLEEP-AID LIQUICAPS® active ingredient*

    100% Money Back Guarantee

    *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®.

    All LEADERTM Brand Products Have A 100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH 
    DUBLIN, OHIO 43017
    www.myleader.com          1-800-200-6313
    Essential to Care™ since 1979

    ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    Product of UAE
    Packaged and Quality Assured in the USA

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

  • Packaging

    Cardi-1

  • INGREDIENTS AND APPEARANCE
    SLEEP-AID DIPHENHYDRAMINE HCL 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0584
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVAL (oblong) Size15mm
    FlavorImprint Code 779
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0584-11 in 1 CARTON09/15/2021
    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 DrugM01009/15/2021
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
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