Label: ALLERGY MEDICINE- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 63981-329-78
  • Packager: COSTCO WHOLESALE CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 15, 2024

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  • Active ingredient (in each 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:
      • runny nose
      • sneezing
  • 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 right away.

  • Directions

    • do not take more than directed
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12 years and over1 to 2 tablets
    children 6 to under 12 years
    		1 tablet
    children under 6 years
    		do not use
  • Other information

    • each tablet contains: calcium 30 mg
    • protect from moisture
    • use by expiration date on package
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    KIRKLAND
    Signature

    COMPARE TO BENADRYL®
    ALLERGY ULTRATAB® TABLETS
    active ingredient*

    NDC 63981-329-78
    ITM. / ART. 536099

    ALLERGY
    MEDICINE

    Diphenhydramine HCl 25 mg

    Antihistamine • Allergy Relief

    For Temporary Relief of:
    Sneezing & Runny Nose
    Itchy, Watery Eyes
    Hay Fever Symptoms
    Itching of Nose or Throat

    Actual Size

    600
    Minitabs

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured
    or distributed by Johnson &
    Johnson Corporation, owner of
    the registered trademark
    Benadryl® Allergy ULTRATAB®
    Tablets.   50844 REV0721K32978

    Manufactured by: LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788 USA
    For: Costco Wholesale Corporation, P.O. Box 34535
    Seattle, WA 98124-1535 USA    1-800-774-2678    www.costco.com

    Kirkland 44-329

    Kirkland 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY MEDICINE 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-329
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-329-78600 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/02/1990
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63981-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(63981-329) , pack(63981-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63981-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(63981-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63981-329)
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