Label: LEADER MAXIMUM STRENGTH SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • 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 June 7, 2012

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  • Active Ingredient (in each softgel)

    Diphenhydramine HCl 50mg

  • Purpose

    Nighttime sleep aid

  • Use

    helps to reduce difficulty falling asleep

  • Warnings

    Do not give to children under 12 years of age


    Do not use this product

    with other products containing diphenhydramine, even one used on skin.

    Ask a doctor or pharmacist before use if you have

    emphysema

    chronic bronchitis

    glaucoma

    difficulty in urination due to an enlargement of the prostate gland

    When using this product

    avoid alcoholic beverages.

    Stop use and ask a doctor if

    sleeplessness persists 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

    adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as
    directed by a doctor

  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.


    KEEP OUTER CARTON FOR COMPLETE
    WARNINGS AND PRODUCT INFORMATION
  • INACTIVE INGREDIENT

    edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

  • Questions or comments?

    Call toll free: 1-800-200-6313

    Distributed by:
    Cardinal Health
    Dublin, Ohio 43017

    All Leader Brand Products are 100% satisfation guaranteed or return to place of purchase for a full refund

  • PRINCIPAL DISPLAY PANEL

    *Compare to Maximum Strength Unisom® SleepGels®

    NDC 37205-0120-64

    Maximum Strength Sleep Aid

    Diphenhydramine HCl

    Helps to reduce difficulty falling asleep

    32 softgels

  • Container Label

    Nighttime Sleep Aid

  • Outer Carton Label

    Nighttime Sleep Aid

  • INGREDIENTS AND APPEARANCE
    LEADER MAXIMUM STRENGTH SLEEP AID  
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-120
    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)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (BLUE) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code P50;A99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-120-641 in 1 BOX
    132 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33806/05/2012
    Labeler - Cardinal Health (097537435)
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