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

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

  • Active ingredient

    (in each gelcap)

    Diphenhydramine HCl USP, 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    ■ for 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 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 reach of children

    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.

  • Directions

    take only one dose per day (24 hours) see Overdose warning

    adults & children 12 years and over

    2 gelcaps 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 # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, 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.

  • PRINCIPAL DISPLAY PANEL

    48 count

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-789
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    AMMONIA (UNII: 5138Q19F1X)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    SHELLAC (UNII: 46N107B71O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorgray (Encapsulated gray color tablets with blue gray opaque and purple opaque hard gelatin shells) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-789-4848 in 1 BOTTLE; Type 0: Not a Combination Product03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33803/15/2019
    Labeler - Pharmacy Value Alliance, LLC (101668460)