Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 

  • NDC Code(s): 0185-0648-01, 0185-0648-10, 0185-0648-30, 0185-0648-53, view more
    0185-0649-01, 0185-0649-10, 0185-0649-30, 0185-0649-53
  • Packager: Eon Labs, Inc.
  • 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 09/11

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

  • Active ingredient (in each capsule)

    Diphenhydramine Hydrochloride 25 mg

    Diphenhydramine Hydrochloride 50 mg

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  • Purpose

    Antihistamine

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  • Uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

    • runny nose and sneezing
    • itching of the nose or throat
    • itchy, watery eyes.
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  • Warnings

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Do not use with ny other product containing diphenhydramine, including products used topically.

    Ask a doctor or pharmacist before use if you are

    • taking tranquilizers or sedatives
    • taking other products containing diphenhydramine

    When using this product

    • Do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breastfeeding ask a health professional before use.

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  • Keep out of the reach of children.

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

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  • Directions

    • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
    • Children 12 years and under: Consult a Doctor
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  • Inactive ingredients

    Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

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  • Storage and Handling

    Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

    Manufactured for Sandoz Inc.

    Princeton, NJ 08540

    Manufactured by Epic Pharma, LLC

    Laurelton, NY 11413

    L1812

    Rev. 11/08

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  • Package Label - Principal Display Panel

    NDC 0185-0648-30

    DiphenhydrAMINE

    Hydrochloride

    Capsules USP

    25 mg

    30 Capsules

    Manufactured for Sandoz Inc.

    Princeton, NJ 08540

    Manufactured by Epic Pharma, LLC

    Laurelton, NY 11413

    Sandoz

    25 mg x 30 Capsules - Label

     

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  • Package Label - Principal Display Panel

    NDC 0185-0649-30

    DiphenhydrAMINE

    Hydrochloride

    Capsules USP

    50 mg

    30 Capsules

    Manufactured for Sandoz Inc.

    Princeton, NJ 08540

    Manufactured by Epic Pharma, LLC

    Laurelton, NY 11413

    Sandoz

    50 mg x 30 Capsules - Label
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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0185-0648
    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
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    ANHYDROUS LACTOSE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color PINK (pink top/clear body) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code E648
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0185-0648-30 30 in 1 BOTTLE
    2 NDC:0185-0648-53 50 in 1 BOTTLE
    3 NDC:0185-0648-01 100 in 1 BOTTLE
    4 NDC:0185-0648-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/01/2000
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0185-0649
    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
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    ANHYDROUS LACTOSE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color PINK (pink top/pink body) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code E649
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0185-0649-30 30 in 1 BOTTLE
    2 NDC:0185-0649-53 50 in 1 BOTTLE
    3 NDC:0185-0649-01 100 in 1 BOTTLE
    4 NDC:0185-0649-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/01/2000
    Labeler - Eon Labs, Inc. (012656273)
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