Label: BANOPHEN- diphenhydramine hcl tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 29, 2025

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

  • WHEN USING

    marked drowsiness may occur
    avoid alcoholic beverages
    alcohol, sedatives, and tranquilizers may increase drowsiness
    use caution when driving a motor vehicle or operating machinery
    excitability may occur, especially in children

  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine HCl

  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83112-555(NDC:0904-5551)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83112-555-591 in 1 PACKET; Type 0: Not a Combination Product01/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/31/2025
    Labeler - Health Department, Oklahoma State (143673015)
    Registrant - Health Department, Oklahoma State (143673015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Department, Oklahoma State143673015repack(83112-555)