Label: BANOPHEN- diphenhydramine hcl capsule

  • NDC Code(s): 71335-0081-0, 71335-0081-1, 71335-0081-2, 71335-0081-3, view more
    71335-0081-4, 71335-0081-5, 71335-0081-6, 71335-0081-7, 71335-0081-8, 71335-0081-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 0904-5307
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

If you are a consumer or patient please visit this version.

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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

  • HOW SUPPLIED

    NDC: 71335-0081-1: 15 Capsules in a BOTTLE

    NDC: 71335-0081-2: 20 Capsules in a BOTTLE

    NDC: 71335-0081-3: 30 Capsules in a BOTTLE

    NDC: 71335-0081-4: 10 Capsules in a BOTTLE

    NDC: 71335-0081-5: 6 Capsules in a BOTTLE

    NDC: 71335-0081-6: 100 Capsules in a BOTTLE

    NDC: 71335-0081-7: 90 Capsules in a BOTTLE

    NDC: 71335-0081-8: 60 Capsules in a BOTTLE

    NDC: 71335-0081-9: 2 Capsules in a BOTTLE

    NDC: 71335-0081-0: 12 Capsules in a BOTTLE

    Repackaged/Relabeled by:

    Bryant Ranch Prepack, Inc.

    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine 50 mg Capsule

    Label
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0081(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, UNSPECIFIED (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:71335-0081-115 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    2NDC:71335-0081-220 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2018
    3NDC:71335-0081-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
    4NDC:71335-0081-410 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2019
    5NDC:71335-0081-56 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2019
    6NDC:71335-0081-6100 in 1 BOTTLE; Type 0: Not a Combination Product05/07/2018
    7NDC:71335-0081-790 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    8NDC:71335-0081-860 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    9NDC:71335-0081-92 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    10NDC:71335-0081-012 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/02/2009
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0081) , RELABEL(71335-0081)
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