Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • NDC Code(s): 46122-440-62, 46122-440-78
  • Packager: Amerisource Bergen
  • 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 November 9, 2021

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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
      • itchy, watery eyes
      • sneezing
      • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • 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 over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use

  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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

    GOOD 
    NEIGHBOR
    PHARMACY® 

    Compare to Benadryl® active ingredient*

    NDC 46122-440-78

    Allergy Relief
    diphenhydramine HCl 25 mg

    Antihistamine 

    Relief of:
    • Sneezing            • Runny Nose
    • Itchy Throat        • Itchy, Watery eyes

    100 Capsules ι 25 mg Each

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL 
    UNDER CAP IS BROKEN OR MISSING 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   REV1117B19012

    Distributed by
    AmerisourceBergen
    1 West First Avenue 
    Conshohocken, PA 19428
    Questions or Concerns?
    www.mygnp.com

    Good Neighbor Pharmacist Brand Products
    SATISFACTION GUARANTEED

    GNP 44-190 REV1117B

    GNP 44-190 REV1117B

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-440
    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:46122-440-781 in 1 CARTON03/15/1990
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:46122-440-622 in 1 CARTON03/15/1990
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/1990
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(46122-440) , pack(46122-440)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(46122-440)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(46122-440)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(46122-440)