CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

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

• do not take more than directed
• do not take more than 6 doses in 24 hours
• mL = milliliter
• only use the dose cup provided 
• find right dose on chart below 
• take every 4 to 6 hours, or as directed by a doctor

• 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

• each 5 mL contains: sodium 4 mg
  
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

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

LEADER 44-018

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0701
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0701-1	1 in 1 CARTON	12/19/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/19/2024

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(70000-0701) , pack(70000-0701)