Label: DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • Active ingredient(in each capsule)

    Diphenhydramine HCL 25 mg
    Diphenhydramine HCL 50 mg

    Purpose

    Antihistamine

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  • Uses:

    • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
    • Sneezing.
    • Nasal congestion.
    • Runny nose.
    • Itchy, watery eyes.
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  • Warnings:
  • Do not use

    • With any other product containing Diphenhydramine HCL, including one applied topically.
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  • 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
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  • 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.
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  • If pregnant or breast-feeding,

    ask a health professional before use.


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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.


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  • 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

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  • Other information:

    • Store at room temperature 15-30  degrees C (59-86 degrees F)
    • Protect from excessive moisture
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  • 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
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68788-9687(NDC:66424-020)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color pink Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code PH014
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9687-1 15 in 1 BOTTLE, PLASTIC
    2 NDC:68788-9687-3 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/27/2013
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68788-9688(NDC:66424-021)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color PINK Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code PH013
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9688-1 15 in 1 BOTTLE, PLASTIC
    2 NDC:68788-9688-3 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/27/2010
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 MANUFACTURE(68788-9687, 68788-9688)
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