Home > Drugs A-Z > Banophen

Banophen (Unit Dose Services)

Available Formats

Dosage Form Package Information Links
CAPSULE 30 CAPSULE in 1 BOTTLE (50436-3762-1) Label Information

Complete Banophen Information

  • Active Ingredient (in each banded capsule)

    Diphenhydramine Hydrochloride 50 mg


  • Purpose

    Antihistamine


  • Use

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat and nose
    • Temporarily relieves these symptoms due to the common cold
      • runny nose
      • sneezing

  • WARNINGS

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

  • Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged 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 drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful 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

    • Take every 4-6 hours
    • Do not take more than 6 doses in 24 hours
    adults and children 12 years of age and over Take 1 capsule (50 mg)
    children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

  • Other Information

    • Store at room temperature, USP.
    • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
    • Protect from moisture
    • Contains lactose

  • Inactive Ingredients

    D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.


  • Questions?

    Questions or comments? (800) 616-2471


  • Distributed by

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


  • HOW SUPPLIED

    Product: 50436-3762

    NDC: 50436-3762-1 30 CAPSULE in a BOTTLE


  • DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE

    Label Image

  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-3762(NDC:0904-5307)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color PINK (banded red around the middle) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code CPC;836
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-3762-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 11/02/2009
    Labeler - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-3762) , RELABEL(50436-3762)