Label: ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride capsule

  • NDC Code(s): 30142-832-48, 30142-832-84
  • 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 January 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    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
    • 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 room temperature between 20-25 °C (68-77 °F)
  • Inactive ingredients

    butylparaben, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, purified water, sodium lauryl sulphate, starch

  • Questions or comments

    1-800-632-6900

  • PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton

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

    NDC 30142-832-84

    Kroger®

    Allergy
    Capsules

    Diphenhydramine HCl
    25 mg
    ANTIHISTAMINE

    OUR PHARMACIST RECOMMENDED

    actual
    size

    TEMPORARILY
    RELIEVES:
    Sneezing Runny Nose
    Itchy, Watery Eyes
    Itchy Throat

    100 CAPSULES

    PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY ANTIHISTAMINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-832
    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)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINK, WHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code S832
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-832-484 in 1 CARTON05/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:30142-832-841 in 1 CARTON05/01/2021
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/01/2021
    Labeler - KROGER COMPANY (006999528)
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