Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 30, 2023

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

View All Sections
  • Active ingredient (in each chewable tablet)

    Diphenhydramine HCl 12.5 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
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages
    • 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

    • find right dose on chart below
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    Age (yr)Dose (chewable tablets)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
    adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • see end flap for expiration date and lot number
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
  • Inactive ingredients

    dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    NDC 79903-189-20

    equate™

    Compare to
    Children’s Benadryl®
    Chewables active
    ingredient*

    childrens
    ALLERGY RELIEF
    Diphenhydramine HCl, 12.5 mg
    Chewable Tablets
    Antihistamine

    Dye-Free

    Grape Flavored

    Actual
    Size

    20 Chewable Tablets

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

    Chew or crush tablets completely
    before swallowing. Do not swallow tablets whole.

    TAMPER EVIDENT: DO NOT USE IF
    PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    Satisfaction guaranteed – Or we’ll replace it or give
    you yourmoney back. For questions or comments
    or to report an undesired reaction or side effect,
    please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716
    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark
    Children’s Benadryl® Chewables.
    50844                                                                ORG121848009

    Equate 44-480

    Equate 44-480

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-189
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorGRAPEImprint Code 44;480
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-189-204 in 1 CARTON06/30/2023
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/30/2023
    Labeler - WALMART INC. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(79903-189) , pack(79903-189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(79903-189)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!