CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution 
Cardinal Health 110, LLC. DBA Leader

----------

Leader 44-018

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 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 the child has

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Keep out of reach of children.

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

Directions

Age (yr)Dose (mL)
children under 2 years do not use 
children 2 to 5 years

do not use unless
directed by a doctor 
children 6 to 11 years 5 mL to 10 mL

Other information

Inactive ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0701-1

DYE-FREE

Children's
Allergy
Relief
Diphenhydramine HCl
12.5 mg / 5 mL Oral Solution
Antihistamine

Clear
Bubble Gum
Flavored Liquid

Ages 6 to 11 Years

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

Alcohol-Free
Sugar-Free

COMPARE TO
CHILDREN’S
BENADRYL®
DYE-FREE
ALLERGY LIQUID
active ingredient*

100% Money
Back Guarantee

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Kenvue Inc., owner
of the registered trademark Children’s Benadryl® Dye-Free Allergy.
50844                 ORG072401836

©2024 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.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CardinalHealth™

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. 

CIN 5922232            REV. 06/24

LEADER 44-018

LEADER 44-018

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0701
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0701-11 in 1 CARTON12/19/2024
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/19/2024
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(70000-0701) , pack(70000-0701)

Revised: 4/2026
Document Id: 75d2b34d-b2db-45e0-8e14-e951bba04c13
Set id: d2dab450-cf82-4be2-a4e2-630295fb59ab
Version: 3
Effective Time: 20260408
 
Cardinal Health 110, LLC. DBA Leader