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Childrens Allergy Relief by CARDINAL HEALTH

Medically reviewed on May 2, 2017

Dosage form: solution
Ingredients: Diphenhydramine hydrochloride 12.5mg in 5mL
Labeler: CARDINAL HEALTH
NDC Code: 70000-0245

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.

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 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

a breathing problem such as chronic bronchitis
glaucoma

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 at 1-800-222-1222

Directions
find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
ml = milliliter

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

5mL to 10 mL

Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other information
each 5 mL contains: sodium 11 mg
store at room temperature
see bottom panel for lot number and expiration date
protect from light
contains low sodium

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C red 40, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0245-1

COMPARE TO CHILDREN'S
BENADRYL® active ingredient*

Children’s Allergy Relief

Diphenhydramine HCl ǀ Antihistamine
12.5 mg/5 mL Oral Solution

Cherry Flavor

For Relief of:

 
Runny Nose,
 
Itchy Throat or Nose,
 
Sneezing,
 
and
 
Itchy, Watery Eyes

4 FL OZ (118 mL)


DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl®.

IMPORTANT: Keep this carton for future reference on full labeling.

 
©2017 Cardinal Health, All Rights Reserved, CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners
 
CARDINAL HEALTH

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

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0245
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine hydrochloride (diphenhydramine) Diphenhydramine hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C RED NO. 40 
glycerin 
POTASSIUM CITRATE 
water 
sodium benzoate 
sorbitol 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0245-11 BOTTLE, PLASTIC in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/02/2017
Labeler - CARDINAL HEALTH (097537435)

 
CARDINAL HEALTH

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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