ALLERGY RELIEF- diphenhydramine hcl tablet, film coated 
Cardinal Health 110, LLC. DBA Leader

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 44-329

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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 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 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12
years and over

1 to 2 tablets
children 6 to under 12
years
1 tablet
children under 6 yearsdo not use

Other information

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel

LEADER

NDC 70000-0136-1

Allergy Relief

Diphenhydramine HCl, 25 mg I Antihistamine

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

24 MINI TABLETS

Actual Size

COMPARE TO BENADRYL® ALLERGY ULTRATAB® active ingredient*
100% Money Back Guarantee

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

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

50844     REV0721C32908

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com      1-800-200-6313
Essential to Care™ since 1979

All LEADER™ Brand Products Have A
100% Money Back Guarantee

Return to place of purchase if not satisfied.

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

Leader 44-329

Leader 44-329

ALLERGY RELIEF 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0136
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
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0136-24 in 1 CARTON03/02/1990
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70000-0136-31 in 1 CARTON03/02/1990
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:70000-0136-12 in 1 CARTON03/02/1990
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/02/1990
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0136)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(70000-0136)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70000-0136)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(70000-0136) , pack(70000-0136)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0136)

Revised: 11/2021
Document Id: e34eb2af-dada-4399-8fc3-fef5cd74fe3e
Set id: 933a54d3-196d-4c5d-b26f-d18b2d2ba1df
Version: 12
Effective Time: 20211117
 
Cardinal Health 110, LLC. DBA Leader