Label: DIPHENHYDRAMINE HCL capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • Active ingredient (in each capsule)

    Diphenhydramine HCL 25 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 have

    • trouble urinating due to enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • if you are taking sedatives or tranquilizers
  • When using this product

    • aAvoid 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 hours
    • Do not take more than 6 doses in 24 hours.
    Adults and children 12 years or over1 to 2 capsule                                     
    Children 6 to under 12 years1 capsule
    Children under 6 yearsask a doctor

  • 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

  • HOW SUPPLIED

    Product: 50090-5744

    NDC: 50090-5744-1 28 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:50090-5744(NDC:66424-020)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 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 PH014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-5744-128 in 1 BOTTLE; Type 0: Not a Combination Product09/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/27/2010
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-5744) , REPACK(50090-5744)
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