Label: ALLERGY RELIEF- diphenhydramine hcl tablet

  • NDC Code(s): 69452-445-24, 69452-445-77
  • Packager: BIONPHARMA INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2026

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 50 mg

  • Purpose

    Antihistamine

  • Uses

    ■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies:
    ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

  • Warnings

    ■ May cause excitability especially in children.

    ■ May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

  • Do not use

    ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.

  • Ask a doctor before use if you have

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

  • Ask a doctor or pharmacist before use

    if you are taking sedatives or tranquilizers.

  • When using this product

    ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

  • Stop use and ask a doctor if

    sleeplessness persisits continuously for more than 2 weeks

  • 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 Centre right away.

  • Directions

    adults and children 12 years and over

    ■ take 1 tablet every 4 to 6 hours, or as directed by the doctor

    ■ do not take more than 6 tablets in 24 hours
    children under 12 yearsdo not use

  • Other information

    ■ each tablet contains: calcium 35 mg■ store between 20-25°C (68-77°F). Protect from light.

    ■ do not use if blister unit is torn or broken

  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

  • Questions or comments?

    call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    †This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength

    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.

    Manufactured for:

    BIONPHARMA INC.
    Princeton, NJ 08540

    MADE IN INDIA

    949129336

    Code: TN/Drugs/TN00002222/2006

    L0001088

    R0625

  • 150''s count

    †Compare tothe active ingredient in Benadryl® Allergy Extra Strength

    a+ health TM

    extra strength
    allergy relief

    diphenhydramine HCl tablets,50 mg

    antihistamine

    dye

    free

    150 tablets

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

    carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-445
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code DH50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-445-774 in 1 CARTON08/11/2025
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69452-445-241 in 1 CARTON08/11/2025
    2150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/11/2025
    Labeler - BIONPHARMA INC. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrBion Pharmaceuticals Private Limited854403569manufacture(69452-445) , pack(69452-445)
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