Label: DIPHENHYDRAMINE HCL capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 4, 2023

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  • 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: 50090-4539

    NDC: 50090-4539-0 30 CAPSULE in a BOTTLE

    NDC: 50090-4539-2 15 CAPSULE in a BOTTLE

    NDC: 50090-4539-3 20 CAPSULE in a BOTTLE

    NDC: 50090-4539-5 10 CAPSULE in a BOTTLE

    NDC: 50090-4539-1 100 CAPSULE in a BOTTLE

  • Diphenhydramine HCL

    Label Image
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4539(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:50090-4539-320 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    2NDC:50090-4539-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    3NDC:50090-4539-510 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    4NDC:50090-4539-030 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    5NDC:50090-4539-215 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2010
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4539) , REPACK(50090-4539)
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