Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • 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 29, 2021

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  • Active ingredient

    (in each gelcap)

    Diphenhydramine HCl USP 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    ■ for relief of occasional sleeplessness

  • Warnings

  • Do Not Use

    ■ for 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

    ■ a breathing problem such as emphysema, or chronic bronchitis

    ■ glaucoma

    ■ difficulty in urination due to enlargement of the prostate gland

  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

  • When using this product

    ■ avoid alcoholic beverages

  • Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 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 the reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults & children 12 years of age and over: 1 gelcap (50 mg) at bedtime if needed, or as directed by a doctor

  • Other information

    ■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.

    ■ avoid high humidity

  • Inactive ingredients

    ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • Diphenhydramine HCl 50 mg RR Gelcaps

    48 count

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-795
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    AMMONIA (UNII: 5138Q19F1X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite (Encapsulated white color tablet with blue gray opaque and light blue opaque hard gelatin shells) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-795-4848 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/01/2018
    Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
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