Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule

  • NDC Code(s): 57344-113-01, 57344-113-02, 57344-113-03
  • Packager: AAA Pharmaceutical, 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 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
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
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  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • 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.

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  • Directions

    • take every 4 to 6 hours
    • do not exceed 6 doses in 24 hours
    *
    12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.
    adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules)
    children 6 to under 12 years of age 12.5 mg* to 25 mg (1 capsule)
    children under 6 years of age ask a doctor
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  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from moisture
    • retain carton for complete product information
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  • Inactive ingredients

    benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 24 Capsule Blister Pack Carton

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    NDC 57344-113-01

    COMPARE TO THE ACTIVE
    INGREDIENT IN BENADRYL®
    ALLERGY KAPSEALS®

    Allergy Relief

    Antihistamine
    Diphenhydramine HCl

    Relieves: • Sneezing • Runny Nose
    • Itchy, Watery Eyes • Itchy Throat

    24 CAPSULES

    Principal Display Panel - 24 Capsule Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-113
    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
    BENZYL ALCOHOL  
    BUTYLPARABEN  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    LACTOSE  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    POLYSORBATE 80  
    PROPYLPARABEN  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color PINK, WHITE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code A;20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-113-01 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:57344-113-02 4 in 1 CARTON
    2 12 in 1 BLISTER PACK
    3 NDC:57344-113-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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