Label: ALLERGY- diphenhydramine hcl tablet, coated

  • NDC Code(s): 30142-329-05, 30142-329-08, 30142-329-12, 30142-329-90
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 18, 2021

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

  • 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:
      • sneezing
      • itchy, watery eyes
      • runny nose
      • 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
    • 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

    • 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
    • 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)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    1-800-632-6900

  • Principal display panel

    COMPARE TO the active ingredient of
    BENADRYL® ALLERGY ULTRATAB® TABLETS
    *See bottom panel

    NDC 30142-329-90

    Kroger®

    Allergy
    Tablets

    Diphenhydramine HCl,
    25 mg
    Antihistamine

    OUR PHARMACIST RECOMMENDED

    actual
    size

    RELIEVES:
    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat

    48 TABLETS

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

    **Benadryl® is a registered trademark of Johnson & Johnson
    Corporation, New Brunswick, NJ 08933. Johnson & Johnson
    Corporation is not affiliated with The Kroger Co. or this product.
    50844 REV1016A32922

    DISTRIBUTED BY
    THE KROGER CO.
    CINCINNATI, OHIO 45202
    QUALITY GUARANTEE
    800-632-6900
    www.kroger.com

    Kroger 44-329

    Kroger 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-329
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    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:30142-329-121 in 1 CARTON06/01/2019
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:30142-329-051 in 1 CARTON06/01/2019
    2400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:30142-329-082 in 1 CARTON06/01/2019
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:30142-329-904 in 1 CARTON06/01/2019
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2019
    Labeler - Kroger Company (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(30142-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(30142-329) , pack(30142-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(30142-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(30142-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(30142-329)