Label: ALLERGY RELIEF- 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 June 17, 2020

If you are a consumer or patient please visit this version.

  • 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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • 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 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?

    1-888-309-9030

  • Principal display panel

    DG™ Health

    Compare to
    active ingredient
    of Benadryl®
    Allergy*

    Allergy Relief

    Diphenhydramine HCl, 25 mg
    Antihistamine

    Temporarily Relieves:
    • Sneezing • Itchy, watery eyes
    • Runny nose • Itchy nose or throat

    Each capsule individually
    banded for your protection

    24 Capsules

    25
    mg each

    100%
    Satisfaction
    Guaranteed!
    (888) 309-9030

    DISTRIBUTED BY
    OLD EAST MAIN CO.
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

    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® Allergy.

    50844    ORG111719008

    DG Health 44-190

    DG Health 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-191
    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 (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:55910-191-082 in 1 CARTON07/30/2020
    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 FINALpart34107/30/2020
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(55910-191) , PACK(55910-191)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55910-191)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55910-191)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55910-191)