Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 70000-0207-1, 70000-0207-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL

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 May 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    (in each banded capsule)

    Diphenhydramine Hydrochloride 25mg

  • 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 child sleepy
    • with any other products 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 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 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 right away.

  • Directions

    • take every 4 to 6 hours
    • 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 at room temperature, USP
  • INACTIVE INGREDIENT

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

  • Questions or Comments?

    (800) 231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed By Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    Essential to Care™ since 1979

    +This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl®

    © 2016 Cardinal Health. All rights Reserved. Cardinal Health, the Cardinal Health Logo, Leadear and the Leader Logo are trademarks or registered trademarks of Cardinal Health. All other marks are property of their respective owners.

  • PRINCIPAL DISPLAY PANEL

    NDC 70000-0207-1

    Allergy Capsules

    Diphenhydramine HCL, 25 mg

    Antihistamine

    For Allergy Relief

    Runny Nose, Itchy Throat, Sneezing and Itchy, Watery Eyes

    24 Capsules

    Compare to Benadryl® active ingredient+

    0835-Cardinal-label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0207
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (Half pink and half clear with white powder inside) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0207-12 in 1 CARTON01/31/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0207-2100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/13/2017
    Labeler - Cardinal Health (097537435)