Label: DIPHENHYDRAMINE HCL capsule

  • NDC Code(s): 71335-0526-0, 71335-0526-1, 71335-0526-2, 71335-0526-3, view more
    71335-0526-4, 71335-0526-5, 71335-0526-6, 71335-0526-7, 71335-0526-8, 71335-0526-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 66424-021
  • Category: HUMAN OTC DRUG LABEL

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 January 6, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient(in each capsule)

    Diphenhydramine HCL 50 mg

    Purpose

    Antihistamine

  • Uses:

    • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
    • Sneezing.
    • Nasal congestion.
    • Runny nose.
    • Itchy, watery eyes.
  • Warnings:


  • Do not use

    • With any other product containing Diphenhydramine HCL, including one applied topically.
  • Ask a doctor or pharmacist before use

    If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf you are taking sedatives or tranquilizers

  • When using this product

    • Avoid alcoholic drinks.
    • Marked drowsiness may occur.
    • Excitability may occur, especially in children.
    • Alcohol, sedatives and tranquilizers may increase drowsiness.
    • Be careful when driving a motor vehicle or operating machinery.
  • 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 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 capsule                                      Children under 12 years ask a doctor**25 mg strength is not available in this package. Do not attempt to break capsules.

  • Other information:

    • Store at room temperature 15-30  degrees C (59-86 degrees F)
    • Protect from excessive moisture
  • Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate


  • Questions? Adverse drug event call:

    1-800-687-0176

  • HOW SUPPLIED

    Product: 71335-0526

    NDC: 71335-0526-1 15 CAPSULE in a BOTTLE

    NDC: 71335-0526-2 20 CAPSULE in a BOTTLE

    NDC: 71335-0526-3 30 CAPSULE in a BOTTLE

    NDC: 71335-0526-4 10 CAPSULE in a BOTTLE

    NDC: 71335-0526-5 6 CAPSULE in a BOTTLE

    NDC: 71335-0526-6 100 CAPSULE in a BOTTLE

    NDC: 71335-0526-7 90 CAPSULE in a BOTTLE

    NDC: 71335-0526-8 60 CAPSULE in a BOTTLE

    NDC: 71335-0526-9 2 CAPSULE in a BOTTLE

    NDC: 71335-0526-0 12 CAPSULE in a BOTTLE

  • Diphenhydramine 50mg Capsule

    Label Image
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0526(NDC:66424-021)
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0526-115 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    2NDC:71335-0526-220 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    3NDC:71335-0526-330 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    4NDC:71335-0526-410 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    5NDC:71335-0526-56 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    6NDC:71335-0526-6100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    7NDC:71335-0526-790 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    8NDC:71335-0526-860 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    9NDC:71335-0526-92 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    10NDC:71335-0526-012 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2010
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0526) , RELABEL(71335-0526)