Label: ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG- diphenhydramine hcl capsule

  • 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 August 1, 2023

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  • Active ingredient (in each banded capsule)

    Diphenhydramine HCL 50 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 symptons due to common cold: 
    • runny nose
    • sneezing
  • Warnings:

  • Do not use

    • to make a child sleepy
    • With any other product containing Diphenhydramine HCL, 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

    • marked 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 over1 capsule                                     
    children under 12 yearsask a doctor

  • Other information

    • Store at 20-25 °C (68-77 °F)
  • 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) 933-6337 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    welmate

    Compare to active ingredient in BENADRYL® Allergy Extra Strength*

    ANTIHISTAMINE

    Allergy Relief

    Diphenhydramine

    HCl Capsules, USP 50 mg

    For temporary relief of:

    Sneezing

    Runny nose

    Itchy watery eyes

    Itchy nose or throat

    1000 CAPSULES

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    welmate Allergy Relief Capsule 50 mg 1000 ct.

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-020
    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
    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
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-020-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2023
    Labeler - YYBA Corporation (006339772)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(73581-020) , analysis(73581-020) , pack(73581-020) , label(73581-020)
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