Label: ALLERGY RELIEF- diphenhydramine hcl capsule, liquid filled

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

Drug Label Information

Updated April 7, 2025

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

  • Warnings

    ■ May cause excitability especially in children.
    ■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

  • Do not use

    ■ Do not use for children under 6 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 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 Center right away.

  • Directions

    ■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours

    adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use this product for children under 6 years of age

  • Other information

    ■ store at 20°C to 25°C (68°F to 77°F)
    ■ avoid high humidity and excessive heat above 40°C (104°F).
    ■ protect from light

  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    †This product is not manufactured or distributed by the owners of Benadryl® Allergy LIQUI-GELS®

    Manufactured for:

    BIONPHARMA
    Princeton, NJ 08540

    MADE IN INDIA

    Mfg. Lic. No.: TN00002123

    2122718

    L0000935

    R1124

  • 48's count

    NDC 69452-453-09

    †Compare to the active ingredient in Benadryl ®Allergy LIQUI-GELS ®†

    a+ health

    dye-free

    allergy refief

    diphenhydramine HCl capsules

    USP, 25 mg
    antihistamine

    48 softgels**

    **liquid-filled capsules

    • sneezing • runny nose
    • itchy, watery eyes • itchy throat or nose

    image001

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-453
    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
    SORBITAN (UNII: 6O92ICV9RU)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (Clear) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code DF25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-453-094 in 1 CARTON12/11/2024
    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 DrugM01212/11/2024
    Labeler - BIONPHARMA INC. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(69452-453)
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