Label: LEADER ALLERGY- diphenhydramine hydrochloride capsule

  • 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 June 28, 2012

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

View All Sections
  • Active ingredient (in each capsule)

    Diphenhydramine hydrochloride 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms of the common cold:
      • runny nose
      • sneezing
    • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy watery eyes.
  • Warnings

    Do not use

    • 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 an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when  operating machinery or driving a motor vehicle

    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, not more than 6 doses in 24 hours
       adults and children 12 years of age and over   take 1 or 2 tablets
       children 6 to under 12 years of age   take 1 tablet
       children under 6 years of age  consult a doctor
    children under 4 years of age
    		do not use
  • Other information


    • store at room temperature 15°-30°C (59°-86°F) in a dry place
    • protect from light
    • do not use if red band around capsule is broken or missing
  • Inactive ingredients

    DandC Red No. 28, FDandC Blue No. 1, FDandC Red No. 40, gelatin, lactose, and starch.

    Questions or comments?

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs.


    Distributed by Cardinal Health

    Dublin, OH 43017

    www.myleader.com   1-800-200-6313

    All leader brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
  • Package/Label Principal Display Panel



    *Compare Benadryl® Allergy Kaplets active ingredient


    Allergy Tablets

    Diphenhydramine Hydrochloride 25 mg

    Antihistimine

    For Allergy Relief

    Runny Nose, Sneezing, Itchy Throat, Itchy, watery eyes

    24 Capsules


    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Allergy Tablets Packaging Label

  • INGREDIENTS AND APPEARANCE
    LEADER ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-277
    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 (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-277-622 in 1 CARTON
    112 in 1 BLISTER PACK
    2NDC:37205-277-781 in 1 CARTON
    2100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/1990
    Labeler - Cardinal Health (097537435)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!