Label: ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

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

Drug Label Information

Updated April 17, 2024

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

  • Active ingredient (in each chewable 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:
      • sneezing
      • runny nose
  • 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
    • glaucoma
    • 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
    • avoid alcoholic beverages
    • 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

    • 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 doses in 24 hours
    adults and children 12 years and over1 to 2 chewable tablets
    children 6 to under 12 years1 chewable tablet
    children under 6 yearsdo not use
  • 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

    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 or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS Health™ 

    Compare to the active
    ingredient in Benadryl®*

    Chewable Tablets

    Allergy Relief

    DIPHENHYDRAMINE
    HYDROCHLORIDE, 25 mg
    CHEWABLE TABLETS
    Antihistamine

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

    For Ages 6 Years & Over

    18 CHEWABLE TABLETS

    Actual Size

    Grape Flavored

    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

    DO NOT USE IF INDIVIDUAL BLISTER UNITS ARE BROKEN OR OPEN.

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

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-18615

    50844     REV0119A68544

    CVS® Quality
    Money Back Guarantee

    CVS 44-685-Allergy

    CVS 44-685-Allergy

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-685
    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
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)  
    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
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code 44;685
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-685-443 in 1 CARTON05/31/2018
    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 DrugM01205/31/2018
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(69842-685)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(69842-685)