Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

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

Drug Label Information

Updated October 31, 2023

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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

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

    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
    • 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 (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 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
    • 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, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

  • Questions?

    Call 1-800-910-6874

  • Principal display panel

    NDC 11673-985-09

    Compare to active ingredient in
    Children’s Benadryl® Chewables*

    children’s
    allergy relief

    diphenhydramine HCl, 12.5 mg chewable tablets
    antihistamine

    relieves:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itchy throat or nose

    chew or crush tablets completely
    before swallowing.

    up&up™

    20 CHEWABLE TABLETS

    GRAPE FLAVOR

    ACTUAL SIZE

    CHEWABLE TABLETS

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

    Dist. by Target Corporation
    Minneapolis, MN 55403
    TM & ©2019 Target Brands, Inc.

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

    50844 ORG121858509

    Target 44-585

    Target 44-585

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-985
    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)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize12mm
    FlavorGRAPEImprint Code 44;585
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-985-094 in 1 CARTON04/01/201905/24/2024
    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 DrugM01204/01/201905/24/2024
    Labeler - Target Corporation (006961700)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11673-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(11673-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11673-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(11673-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11673-985)
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