Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 0363-9835-01, 0363-9835-02, 0363-9835-06
  • Packager: Walgreen 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 29, 2022

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  • Drug Facts

    Active ingredient (in each capsule)

    Diphenhydramine HCI 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

     temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  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

     trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use ifyou are taking sedatives or tranquilizers

    When using this product

     marked drowsiness may occur

     avoid alcoholic drinks
     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 (1-800-222-1222) right away.

  • Directions

     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 of age and over1 to 2 capsules
    children 6 to under 12 years of age1 capsule
    children under 6 years of agedo not use

  • Other information

     store in a dry place at 15° – 30°C (59° – 86°F)
     protect from moisture

  • INACTIVE INGREDIENT

    D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2021 Walgreen Co.
    PRODUCT OF JAPAN

    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

    †Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands

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

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    Compare to the active ingredient in Benadryl® Allergy††

    NDC 0363-9835-01

    Relieves allergy symptoms

    Allergy Relief

    Diphenhysramine HCl 25 mg / Antihistamine

    Relief of runny nose, sneezing, itchy throat & itchy, watery eyes

    100 Capsules

    0835-Walgreen

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9835
    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
    GELATIN (UNII: 2G86QN327L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (Half Pink & Half Clear with white powder inside) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9835-011 in 1 CARTON09/07/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-9835-06365 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2021
    3NDC:0363-9835-02600 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/07/2021
    Labeler - Walgreen Company (008965063)
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