Label: BANOPHEN- diphenhydramine hcl liquid

  • 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 September 25, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl USP 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, including one applied topically.

    Ask a doctor before use if you have

    • glaucoma
    • a sodium restricted diet
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    • use only with enclosed dosing cup. Do not use with any other device
    • find right dose on chart below
    • mL = milliliter
    adults and children 12 years and over10-20mL (25 mg to 50 mg)
    children 6 to under 12 years5-10mL (12.5 mg to 25 mg)
    children 2 to 5 years of agedo not use unless directed by a doctor
    children under 2 years of agedo not use
  • Other information

    • each (5 mL) contains: sodium 7 mg
    • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
    • store at room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

  • Questions or comments?

    (800) 616-2471

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    MAJOR ®
    NDC 0904-1228-00
    TAMPER-EVIDENT

    Banophen™
    ALLERGY

    Antihistamine
    12.5 mg Diphenhydramine HCl USP

    ALCOHOL FREE

    FOR THE TEMPORARY
    RELIEF OF:
    Upper Respiratory Allergies
    Hay Fever
    The Common Cold

    Compare to the active ingredient
    of Benadryl ® Allergy Liquid*

    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1228
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHERRY (UNII: BUC5I9595W)  
    Product Characteristics
    Colorred (Bluish-Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-1228-201 in 1 CARTON11/20/200601/31/2021
    1NDC:0904-1228-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/20/2006
    Labeler - Major Pharmaceuticals (191427277)
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