Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 36800-690-36
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 04/13

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • Uses

    • temporarily relieves 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 of 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
    • do not take more than 6 doses in 24 hours
     adults and children 12 years of age and over  take 1 to 2 tablets 
     children 6 to under 12 years of age  take 1 tablet
     children under 6 years of age  do not use this product in children under 6
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  • Other information

    • each tablet contains: calcium 25 mg/tablet
    • store at room temperature 15°-30°C (59°-86°F)
    • protect from light and moisture
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

    * contains one or more of these ingredients

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  • Questions or comments?

    1-888-423-0139

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  • Principal Display Panel

    COMPLETE ALLERGY RELIEF

    Allergy Tablets

    DIPHENHYDRAMINE HCl 25 mg • ANTIHISTAMINE

    For allergy relief

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

    COMPARE TO BENADRYL® ALLERGY ULTRATAB® active ingredient**

    TABLETS

    **This product is not manufactured or distributed by McNeil Consumer Healthcare , Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy ULTRATAB®.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60007

    1-888-423-0139 ©TOPCO  topcare@topco.com

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE, USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Product Label

    Diphenhydramine 25 mg

    Top Care Allergy Tablets

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-690
    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  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    TALC  
    TITANIUM DIOXIDE  
    ALUMINUM OXIDE  
    EGG PHOSPHOLIPIDS  
    WATER  
    Product Characteristics
    Color PINK Score no score
    Shape CAPSULE Size 12mm
    Flavor Imprint Code T61;V25;S4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-690-36 3 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 03/31/2013
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
    Registrant - P and L Development of New York Corporation (800014821)
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