Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 0363-8350-01, 0363-8350-02, 0363-8350-06
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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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 if you 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 over 1 to 2 capsules
    children 6 to under 12 years of age 1 capsule
    children under 6 years of age do not use

  • Other information

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

     protect from moisture

     do not use if imprinted safety seal under cap is broken or missing or if red band around capsule is broken or missing

  • INACTIVE INGREDIENT

    corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    Walgreens Pharmacist Recommended.
    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®.

    DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED walgreens.com ©2022 Walgreen Co.

    PRODUCT OF CHINA. MANUFACTURED AND PACKAGED IN THE USA USING DOMESTIC AND IMPORTED INGREDIENTS.

  • PRINCIPAL DISPLAY PANEL

    NDC 0363-8350-02

    Compare to the active ingredient in Benadryl® Allergy††

    Allergy
    Relief
    DIPHENHYDRAMINE HCl 25 mg / ANTIHISTAMINE
    • Relief of runny nose, sneezing,
    itchy throat & itchy, watery eyes

    600 Capsules

    walgreen label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8350
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    Colorpink ( HALF PINK AND HALF CLEAR WITH WHITE POWDER INSIDE AND SEALED WITH RED BAND) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8350-06365 in 1 BOTTLE; Type 0: Not a Combination Product08/12/2022
    2NDC:0363-8350-02600 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
    3NDC:0363-8350-011 in 1 CARTON02/02/2024
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/12/2022
    Labeler - Walgreen Company (008965063)
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