Label: BANOPHEN- diphenhydramine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    •
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    o
    runny nose
    o
    itchy, watery eyes
    o
    sneezing
    o
    itching of the nose or throat
    •
    temporarily relieves these symptoms due to the common cold:
    o
    runny nose
    o
    sneezing 
  • Warnings

    Do not use

    •
    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

    •
    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 

    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

    •
    do not take more than directed
    •
    take every 4 to 6 hours, or as directed by a doctor
    •
    do not take more than 6 times in 24 hours

    adults and children 12
    years and over

    1 to 2 tablets

    children 6 to under 12
    years

    1 tablet

    children under 6 years

    do not use
  • Other information

    •
    each tablet contains: calcium 30 mg
    •
    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    •
    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    •
    protect from moisture
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    (800)-616-2471

  • Principal Display Panel

    NDC 71205-611-20

    Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*

    Banophen
    Diphenhydramine HCl
    25 mg
    Antihistamine / Allergy Relief

    Relieves
    Sneezing,  Runny Nose,
    Itchy Throat and
    Itchy, Watery Eyes

    Actual Size

    20 Minitabs

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
    50844    REV1220M32908

    Rev. 03/21   M-17   Re-order No. 250050

    Distributed by:
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA

    Repackaged by:
    PROFICIENT RX LP
    Thousand Oaks, CA 91320

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    71205-611-20
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-611(NDC:0904-5551)
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-611-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2021
    2NDC:71205-611-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2021
    3NDC:71205-611-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2021
    4NDC:71205-611-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/02/1990
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-611) , RELABEL(71205-611)
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