Label: MAXIMUM STRENGTH NIGHTTIME SLEEP-AID- diphenhydramine hcl 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 October 11, 2017

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  • Drug Facts 

    Maximum Strength Nighttime Sleep-Aid

  • Purpose

    Nighttime Sleep-Aid

  • Active Ingredient (in each softgel) 

    Diphenhydramine HCL 50mg 

  • Uses

    • Relief of occasional sleeplessness
  • Warnins 

    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 antihistamine and nighttime cold/flu products
  • 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 
    • heart disease 
  • Ask your doctor or pharmacist before use if you are

    • taking sedative or tranquilizers or any other sleep-aid.
  • When using this product

    • drowsiness will occur
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • alcohol, sedatives and tranquilizers may increase 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 childern. 

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sighs or symptoms.

  • Directions

    • Do not take more than directed (see overdosage warning) 
    • Adults and children 12 years and over: Take 1 softgel at bedtime if needed or as directed by a doctor
    • Children under 12 years of age: Do not use
  • Other Information

    • Store at 15°-30°C (59°-86°F)
    • Read all product information before using 
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive Ingredients

    • FD&C Blue#1
    • Gelatin
    • Glycerin
    • Polyethylene glycol
    • Polyvinyl acetate phthalate
    • Polyvinyl glycol
    • Sorbitol
    • Titanium Dioxide
    • Water
  • Questions or Comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

  • Maximum Strength Nighttime Sleep-AidDiphenhydramine HCL 50mg / Nighttime Sleep-Aid 16  Softgels

    afe & Non-Habit Forming
    Get to sleep Fast
    Sleep Soundly
    Wake Refreshed

    Compare to Unisom® Sleepgels® active ingredients

    Max.Strength Nighttime Sleep-Aid

    Distributed by:

    Healthlife of USA LLC
    Rahway
    NJ 07065
    www.healthlifeofusa.com

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-117
    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)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-117-161 in 1 CARTON05/02/2017
    116 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33805/02/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Healthlife of USA079656178repack(69517-117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Limited915664486manufacture(69517-117) , pack(69517-117)
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