Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 70000-0598-1, 70000-0598-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • Drug Facts

    Active ingredient (in each banded 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 n 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
    • be careful 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 (1-800-222-1222).

  • 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 this product in children under 6 years of age

  • Other information

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

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF PRODUCT APPEARS TO BE TAMPERED WITH OR IF BLISTER UNIT IS BROKEN OR TORN. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. KEEP THIS BOX FOR IMPORTANT INFORMATION.

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313

    Product of China.

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

  • PRINCIPAL DISPLAY PANEL

    Allergy Capsules

    Diphenhydramine HCl, 25 mg | Antihistamine

    For Allergy Relief:
    Runny Nose
    Itchy Throat
    Sneezing
    Itchy, Watery Eyes

    COMPARE TO BENADRYL® ALLERGY active ingredient*

    24 Capsules

    Cardinal Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0598
    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 RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    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:70000-0598-2100 in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
    2NDC:70000-0598-12 in 1 CARTON07/07/2022
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/07/2022
    Labeler - Cardinal Health (063997360)
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