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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2022

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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 finalpart34107/01/2019
    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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