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banophen (Major Pharmaceuticals)

Available Formats

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LIQUID 1 BOTTLE in 1 CARTON (0904-1228-20) > 118 mL in 1 BOTTLE Label Information

Complete banophen Information

  • 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 over 10-20mL (25 mg to 50 mg)
    children 6 to under 12 years 5-10mL (12.5 mg to 25 mg)
    children 2 to 5 years of age do not use unless directed by a doctor
    children under 2 years of age do 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

    Banophenâ„¢
    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 Type HUMAN OTC DRUG Item Code (Source) NDC:0904-1228
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED (Bluish-Red) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-1228-20 1 in 1 CARTON 11/20/2006
    1 NDC:0904-1228-00 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/20/2006
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Bio-Pharm, Inc. (801652546)
    Establishment
    Name Address ID/FEI Business Operations
    Bio-Pharm, Inc. 801652546 MANUFACTURE(0904-1228) , ANALYSIS(0904-1228) , PACK(0904-1228) , LABEL(0904-1228)