Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated

  • 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    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

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

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

    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
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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. (1-800-222-1222)

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  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12 years and over 1 to 2 tablets
    children 6 to under 12 years 1 tablet
    children under 6 years do not use
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  • Other information

    • each tablet contains: calcium 15 mg
    • store between 20 - 25°C (68 - 77°F). Avoid high humidity. Protect from light.
    • do not use if carton or pouch is opened or torn
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    carnauba wax, crospovidone, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

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  • Questions or comments?

    call 1-877-717-2824 or www.benadryl.com

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  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by:
    Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

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  • PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

    Benadryl®

    ALLERGY

    Diphenhydramine HCl | antihistamine

    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    2
    ULTRATAB™*
    TABLETS

    25 mg EACH *small tablet size

    Lil'
    Drug Store®

    Principal Display Panel - 2 Tablet Pouch Carton
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  • INGREDIENTS AND APPEARANCE
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66715-9706(NDC:50580-226)
    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
    carnauba wax  
    crospovidone  
    D&C red no. 27  
    aluminum oxide  
    calcium phosphate, dibasic, dihydrate  
    hypromelloses  
    magnesium stearate  
    cellulose, microcrystalline  
    polyethylene glycols  
    polysorbate 80  
    stearic acid  
    titanium dioxide  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code B;WL;25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9706-1 1 in 1 CARTON
    1 2 in 1 POUCH
    2 NDC:66715-9706-2 2 in 1 CARTON
    2 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 09/16/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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