Label: ALLERGY RELIEF- diphenhydramine hcl tablet

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

Drug Label Information

Updated June 23, 2025

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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 marked drowsiness; alcohol, sedatives, and tranquilizres 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
    ■ 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

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

    Stop use and ask a doctor if

    sleeplessness persists 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 a doctor

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

  • Other information

    ■ each tablet contains: calcium 36 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, 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.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE GOODLETTSVILLE, TN 37072

    MADE IN INDIA

    CODE: TN/DRUGS/TN00002222/2006

    100%

    Satisfaction Guaranteed!

    (888) 309-9030

    949129331

    L0000959

    R0225

  • carton

    †Compare to the

    active ingredient of
    Benadryl® Allergy

    Extra Strength

    DG TM health

    Extra Strength

    Allergy Relief

    diphenhydramine HCl Tablets, 50 mg
    Antihistamine

    Relieves:
    • Sneezing • Itchy throat or nose
    • Runny nose • Itchy, watery eyes

    50

    mg each

    24 Tablets

    carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-450
    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
    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:55910-450-122 in 1 CARTON06/24/2025
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/24/2025
    Labeler - DOLGENCORP INC (068331990)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrBion Pharmaceuticals Private Limited854403569manufacture(55910-450) , pack(55910-450)
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