ALLERGY RELIEF CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
Cardinal Health (Leader) 70000

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Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

age (yr)dose (mL)
 children 6 to 11 years 5 mL to 10 mL
 children 2 to 5 years do not use unless directed by a doctor
 children under 2 years do not use

Other information

Inactive ingredients

anhydrous citric acid, D&C red #33, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO CHILDREN'S BENADRYL® ALLERGY active ingredient*

Children's

Allergy Relief

Diphenhydramine HCI

Oral Solution, 12.5 mg/5mL

Antihistamine

Bubble Gum Flavor

Ages 6 to 11 years

Relieves

Sneezing

Runny Nose

Itchy, Watery Eyes

Itching of the Nose or Throat

Alcohol-Free

Dosing Cup included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Product Label

Diphenhydramine HCI 12.5 mg

LEADER Children's Allergy Relief

ALLERGY RELIEF  CHILDRENS ALLERGY
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0492
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)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0492-11 in 1 BOX02/28/2019
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 DrugM01202/28/2019
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 3/2024
Document Id: fd3e4329-e0ae-4390-ab3d-5485d3449b96
Set id: 0ca9069c-ca3a-4e67-a5c6-08f9456a1d64
Version: 4
Effective Time: 20240304
 
Cardinal Health (Leader) 70000