Label: BANOPHEN- diphenhydramine hcl capsule

  • NDC Code(s): 0904-5307-60, 0904-5307-80
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • 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

    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 overTake 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 in a dry place at 15° – 30°C (59° – 86°F).
    • 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?1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed by: MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    (800) 616-2471

    www.majorpharmaceuticals.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Major

    NDC 0904-5307-80

    BENOPHEN

    Complete Allergy Medication

    Diphenhydramine HCl 50 mg

    ANTIHISTAMINE
    For the temporary relief from symptoms of:
    • Upper Respiratory Allergies • Hay Fever

    1000 CAPSULES

    Each Capsule Individually Banded For Your Protection

    THIS LARGE PACKAGE SIZE FOR DISPENSING PURPOSE ONLY

    Major Label

  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5307-60100 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2009
    2NDC:0904-5307-801000 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/02/2009
    Labeler - Major Pharmaceuticals (191427277)
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