Label: ALLERGY RELIEF 25 MG- diphenhydramine hcl 25mg capsule

  • NDC Code(s): 73057-348-03, 73057-348-08, 73057-348-11
  • Packager: Ulai Health LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2025

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  • Active ingredient (in each banded capsule)

    Diphenhydramine HCl 25 mg

  • 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 the 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

    • 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

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially 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 exceed 6 doses in 24 hours
     adults and children 12 years and over 1 to 2 capsules
     children 6 to under 12 years 1 capsule
     children under 6 yearsask a doctor

  • Other information

    • store at 20-25 oC (68-77 oF)
  • Inactive ingredients

    black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

  • Questions or comments?

    (866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-348-08

    Manufactured in the USA

    *COMPARE TO the active ingredient in

    BENADRYL ®ALLERGY ULTRATAB ®

    ALLERGY RELIEF

    Antihistamine - Diphenhydramine HCl 25 mg

    • Itchy, Watery Eyes • Runny Nose

    • Itchy Throat • Sneezing

    100 CAPSULES

    Ulai Allergy Relief 100ct Label.jpg

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 25 MG 
    diphenhydramine hcl 25mg capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-348
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink (Pink/ Clear) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-348-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2019
    2NDC:73057-348-0324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2019
    3NDC:73057-348-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01007/01/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(73057-348) , analysis(73057-348) , pack(73057-348) , label(73057-348)
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