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 June 5, 2012

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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

    • 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 hours
    • Do not take more than 6 doses in 24 hours.
    Adults and children 12 years or over
    		1 to 2 capsule                                     
    Children 6 to under 12 years
    		1 capsule
    Children under 6 years
    		ask 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

    Diphenhydramine HCL 25 mg Capsules

    Bottles of 10
    		NDC 54868-0026-5
    Bottles of 20
    		NDC 54868-0026-6
    Bottles of 30
    		NDC 54868-0026-1
    Bottles of 60
    		NDC 54868-0026-7
    Bottles of 90
    		NDC 54868-0026-8
    Bottles of 100
    		NDC 54868-0026-0
    Bottles of 1000
    		NDC 54868-0026-4


    Relabeling and Repackaging by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146
  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine HCL Capsules

    25 mg

    image of label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0026(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 (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:54868-0026-0100 in 1 BOTTLE, PLASTIC
    2NDC:54868-0026-130 in 1 BOTTLE, PLASTIC
    3NDC:54868-0026-41000 in 1 BOTTLE, PLASTIC
    4NDC:54868-0026-510 in 1 BOTTLE, PLASTIC
    5NDC:54868-0026-620 in 1 BOTTLE, PLASTIC
    6NDC:54868-0026-760 in 1 BOTTLE, PLASTIC
    7NDC:54868-0026-890 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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