Label: ALLERGY RELIEF- diphenhydramine hci tablet, film coated

  • 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 7, 2021

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

  • Active ingredient (in each tablet)

    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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    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.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12
    years and over
     1 to 2 tablets
    children 6 to under 12
    years
     1 tablet
     children under 6 years do not use
  • Other information

    • each tablet contains: calcium 30 mg
    • 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

    corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    equate™

    NDC 49035-164-12

    Compare to Benadryl® Allergy Ultratabs® Active Ingredient*

    Dye Free
    Allergy Relief
    Diphenhydramine HCI, 25 mg
    Antihistamine

    Easy to Swallow
    Allergy relief for:
    • Sneezing        • Itchy, watery eyes
    • Runny nose    • Itchy throat

    25
    mg
    EACH

    100
    TABLETS

    Actual Size

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

    Satisfaction guaranteed – For questions
    or comments please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

    PRODUCT OF INDIA, AND JAPAN

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy Ultratabs®.
    50844                                   REV0419A61412

    Equate 44-614

    Equate 44-614

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hci tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-164
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;614
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-164-121 in 1 CARTON08/15/2018
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/15/2018
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(49035-164) , pack(49035-164)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-164)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-164)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-164)