Label: DIPHENHYDRAMINE HCL capsule

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 16, 2023

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  • Active Ingredient (in each capsule)

    Diphenhydramine HCL 25 mg
    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 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 Dioxid, Sodium Lauryl Sulfate

  • Principal Display Panel

    Diphenhydramine HCL Capsules USP 25mg
  • Principal Display Panel

    Diphenhydramine HCL Capsules USP 50mg
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9687(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:68788-9687-010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2013
    2NDC:68788-9687-115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2013
    3NDC:68788-9687-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/27/2013
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9688(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:68788-9688-115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2010
    2NDC:68788-9688-330 in 1 BOTTLE, PLASTIC; 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 - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-9687, 68788-9688)
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