Label: ALLERGY RELIEF DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 70000-0585-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • 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 September 9, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each softgel)

    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 to 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.
    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • 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 and older 1 to 2 softgels
    children 6 to under 12 years 1 softgel
    children under 6 years do not use

  • Other information

    •store at 25°C (77°F) in a dry place
    •protect from light, heat and moisture

  • Inactive ingredients

    edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-888-577-8033 Monday-Friday 8am-4pm EST

  • SPL UNCLASSIFIED SECTION

    LEADER

    DYE-FREE

    Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat

    COMPARE TO BENADRYL® DYE-FREE ALLERGY active ingredient*

    100% Money Back Guarantee

    READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

    All LEADERTM Brand Products Have A 100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313
    Product of UAE
    Packaged and Quality Assured in the USA

    ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

  • Packaging

    Cardi-0585-1

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF DIPHENHYDRAMINE HCL 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0585
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Coloryellow (pale yellow transparent) Scoreno score
    ShapeOVAL (oblong) Size15mm
    FlavorImprint Code 780
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0585-12 in 1 CARTON09/15/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/15/2021
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Registrant - Strive Pharmaceuticals Inc. (080028013)