Label: NIGHTTIME SLEEP AID- diphenhydramine hcl capsule

  • 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 November 15, 2012

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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

    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 before use if you have

    • emphysema
    • chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the prostate gland

    Ask doctor or pharmacist before use if you are now taking

    sedatives or tranquilizers
  • 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)

    • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

  • Inactive ingredients

    edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.
  • Questions or comments ?

    call toll free 1-877-753-3935

  • Principal Display Panel

    *Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®

    Nighttime Sleep Aid

    Diphenhydramine HCl 50 mg

    Helps to reduce difficulty falling asleep

    THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

  • Product Label

    Best Choice nighttime sleep aid

    Diphenhydramine HCl 50 mg

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-230
    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
    ColorBLUEScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code P50;A99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-230-162 in 1 CARTON
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/26/2010
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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