Label: NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl capsule

  • NDC Code(s): 70000-0426-1
  • Packager: Cardinal Health (Leader) 70000
  • 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 September 30, 2022

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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness.

  • 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
    • 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 drinks.

    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 (1-800-222-1222).

  • Directions

    • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
  • Other information

    • store between 15-30°C (59-86°F)
  • Inactive ingredients

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

    *contains one or more of these ingredient

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO UNISOM® SLEEPGELS® active ingredient†

    Sleep Aid

    Diphenhydramine HCl, 50 mg | Nighttime Sleep-Aid

    For Relief of Occasional Sleeplessness

    Non-Habit-Forming

    SOFTGELS**

    **One Softgel Per Dose

    **This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

  • Package Label

    Diphenhydramine HCI 50 mg

    LEADER Sleep Aid

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID  MAXIMUM STRENGTH
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0426
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code P50;A99;D50;AP018
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0426-11 in 1 BOX02/28/201912/27/2024
    132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33802/28/201912/27/2024
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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