Label: CHILDRENS ALLERGY RELIEF DYE FREE- diphenhydramine hcl tablet, chewable

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

Drug Label Information

Updated April 22, 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

    • avoid alcoholic beverages
    • marked drowsiness may occur
    • 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

    • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS
    Health®

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

    Chewable Tablets

    Children's
    Allergy Relief

    DIPHENHYDRAMINE
    HYDROCHLORIDE, 12.5 mg
    CHEWABLE TABLETS
    Antihistamine

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

    DYE
    FREE

    Actual Size
    Bubble Gum Flavored

    Child-Resistant Packaging

    18 CHEWABLE TABLETS

    Chew or crush tablets completely before swallowing.

    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             REV1218C66944

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2021 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS

    CVS® Quality
    Money Back Guarantee

    CVS 44-669

    CVS 44-669

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF  DYE FREE
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-869
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorBUBBLE GUMImprint Code 44;669
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-869-443 in 1 CARTON03/20/2015
    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 DrugM01203/20/2015
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(59779-869)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(59779-869)
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