Label: NIGHTIME SLEEP AID- diphenhydramine 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 May 21, 2018

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  • Active Ingredient

    (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep aid

  • Uses

    • For relief of occasional sleeplessness.
  • Directions

    • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
    • children under 12 years:do not use
  • Warnings

    Do not use

    • in 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

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

      Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

      When using this product

    • avoid alcoholic drinks

      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)

  • Other Information

    • save carton for full directions and warnings
  • Inactive Ingredients

    Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

  • Questions or Comments

    Call 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    29c54705-figure-01
    29c54705-figure-02

    DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

    NDC:76168-065-37  16 Softgel Liquid filled

  • INGREDIENTS AND APPEARANCE
    NIGHTIME SLEEP AID 
    diphenhydramine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-065
    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 GLYCOL 1000 (UNII: U076Q6Q621)  
    SORBITOL (UNII: 506T60A25R)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 206
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-065-3716 in 1 BOTTLE03/31/2014
    11 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2014
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)
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