Label: ALLERGY- diphenhydramine hcl capsule

  • NDC Code(s): 30142-290-12, 30142-290-22
  • 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 April 6, 2020

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

  • Active ingredient (in each banded capsule)

    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

    • 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
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule 
    children under 6 yearsdo not use

  • Other information

    • 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

    butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

  • Questions or comments?

    1-800-632-6900

  • Principal display panel

    COMPARE TO active ingredient of BENADRYL®
    *See bottom panel

    Kroger®                                    NDC 30142-290-12

    Allergy Capsules

    Diphenhydramine HCl 25 mg
    Antihistamine

    Relieves:
    Sneezing, Runny Nose
    Itchy, Watery Eyes
    Itchy Throat

    100 CAPSULES

    actual size

    •Our Pharmacists Recommend•

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

    *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 REV1117A19012

    DISTRIBUTED BY
    THE KROGER CO.
    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE
    www.kroger.com

    Kroger 44-190

    Kroger 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-290
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINK, WHITEScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-290-224 in 1 CARTON05/15/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:30142-290-121 in 1 CARTON05/15/2019
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/15/2019
    Labeler - Kroger Company (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(30142-290) , PACK(30142-290)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(30142-290)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(30142-290)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(30142-290)