Label: BENADRYL ALLERGY- diphenhydramine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 3, 2025

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  • Drug Facts

  • Active ingredient (in each tablet)

    Diphenydramine HCl 25mg

    Purpose

    Antihistamine

  • 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 common cold:
    • runny nose
    • sneezing
  • 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 bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilzers

    When using this product

    • marked drawsiness 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, espesially 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)

  • 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 over1 to 2 tablets
     children 6 to under 12 years1 tablet
    children under 6 yearsdo not use

  • Other information

    • each tablet contains:calcium 15 mg
    • store between 20-25°C (68°-77°F). Protect from light.
    • do not use if pouch is torn or damaged
  • Inactive ingredients

    carnauba wax, croscarmellose sodium, D&C red no.27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    call 1-877-717-2824(toll-free) or 215-273-8755(collect)

  • Package Labeling:

    Corton LabelPacket label

  • INGREDIENTS AND APPEARANCE
    BENADRYL ALLERGY 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-528(NDC:50580-226)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code B;WL;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50269-528-002 in 1 BOX06/04/2012
    120 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/04/2012
    Labeler - JC World Bell Wholesale Co., Inc. (805257581)
    Registrant - JC World Bell Wholesale Co., Inc. (805257581)
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