Label: BANOPHEN- diphenhydramine hcl 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 May 26, 2021

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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:
      • runny nose
      • itchy, watery eyes
      • sneezing
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • 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

  • HOW SUPPLIED

    Product: 50090-5546

    NDC: 50090-5546-0 12 TABLET in a BLISTER PACK / 2 in a CARTON

  • BANOPHEN (DIPHENHYDRAMINE HCL) TABLET

    Label Image
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5546(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:50090-5546-02 in 1 CARTON05/17/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/02/1990
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-5546)
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