Label: LEADER NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

  • 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 January 11, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL dose cup)

    Diphenhydramine HCl 50 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 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

    a breathing problem such as asthma, emphysema, or chronic bronchitis
    glaucoma
    difficulty in urination due to enlargement of the prostate gland
    heart disease

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.

    When using this product

    avoid alcoholic beverages and other drugs that cause drowsiness
    drowsiness will occur
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning:

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222

  • Directions

    take only one dose per day (24 hours) – see Overdose warning
    Measure with dosing cup provided.

    adults & children 12 yrs & over

    One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

    Children under 12 yrs

    Do not use

  • Other information

    each 30 mL dose contains: sodium 23 mg
    store at room temperature
    protect from light. Does not meet USP <671>
  • Inactive ingredients

    anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    LEADER

    NDC 70000-0174-1

    Nighttime Sleep-aid

    Diphenhydramine HCl

    COMPARE TO ZZZQUIL® active ingredient*

    100% money Back Guarantee

     
    Non-habit forming

    Berry flavor

    Naturally & Artificially Flavored

     
    Non-habit forming

    12 FL OZ (354 mL)

    ©2016 Cardinal Health, All Rights Reserved CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal health.

    Failure to follow these warnings could result in serious consequences.

    TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

    DISTRIBUTED BY: CARDINAL HEALTH

    DUBLIN,OHIO 43017

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

    *This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark ZzzQuil®.

    Leader Nighttime Sleep Aid Berry Flavor 12FL OZ 354 mL
  • INGREDIENTS AND APPEARANCE
    LEADER NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0174
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0174-1354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33801/17/2017
    Labeler - CARDINAL HEALTH (097537435)