Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • NDC Code(s): 50804-091-08
  • Packager: Geiss, Destin & Dunn Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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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
      • itching of the nose or throat
      • itchy, watery eyes
      • sneezing
    • 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
    • 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

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • 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.

  • Directions

    • take every 4 to 6 hours
    • do not take more than 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 years
    		do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    GOODSENSE®

    NDC 50804-091-08

    Allergy Relief

    Diphenhydramine HCI, 25 mg
    Antihistamine

    Sneezing,
    Itchy, Watery Eyes
    Runny Nose,
    Itchy Throat

    *Compare to the active ingredient
    of Benadryl®

    actual size

    24 Capsules

    actual size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
    OR IF BLISTER UNIT IS TORN OR BROKEN OR IF
    RED BAND AROUND CAPSULE IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark Benadryl®.
    50844            REV1117A19008

    Distributed by: Perrigo Direct, Inc.
    Peachtree City, GA 30269
    www.PerrigoDirect.com (1-800-426-9391)
    GoodSense® is a registered trademark of
    L. Perrigo Company.

    Good Sense 44-190

    Good Sense 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-091
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink, whiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-091-082 in 1 CARTON06/02/2020
    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 DrugM01206/02/2020
    Labeler - Geiss, Destin & Dunn Inc. (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50804-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(50804-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(50804-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50804-091)
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