LEADER ALLERGY - diphenhydramine hydrochloride capsule 
Cardinal Health

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.

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Leader Allergy Capsules Drug Facts

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

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

   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


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

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)

Revised: 6/2012
Document Id: 3c672e00-eab5-4d40-a7d8-3deb20a2578b
Set id: 71df4d09-4d46-452e-8332-4af0be641c08
Version: 3
Effective Time: 20120628
 
Cardinal Health