Label: ALLERGY RELIEF CHILDRENS- diphenhydramine hcl tablet, chewable

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

Drug Label Information

Updated April 20, 2024

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  • 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 (1-800-222-1222) 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 over

    2 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
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Premier
    Value®

    *COMPARE TO THE ACTIVE INGREDIENT
    IN CHILDREN’S BENADRYL® CHEWABLES

    Children's
    Allergy Relief

    Diphenhydramine HCl 12.5 mg Chewable Tablets
    ANTIHISTAMINE

    Relief for:
    • Sneezing     • Itchy throat
    • Runny nose • Itchy, watery eyes

    Chew or crush tablets completely
    before swallowing.

    18 Chewable
    Tablets

    Cherry flavored

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

    *This product is not manufactured or distributed by Johnson
    & Johnson Corporation, owner of the registered trademark
    Children’s Benadryl® Chewables.
    50844      REV1218A59944

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

    If for any reason you are not satisfied
    with this product, please return it to the
    store where purchased for a full refund.

    Premier Value 44-599

    Premier Value 44-599

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  CHILDRENS
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-051
    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
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    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
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorCHERRYImprint Code 44;599
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-051-183 in 1 CARTON04/25/2011
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/25/2011
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(68016-051) , pack(68016-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(68016-051)
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