CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hydrochloride solution

Childrens Dye Free Allergy Relief by

Drug Labeling and Warnings

Childrens Dye Free Allergy Relief by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 throat or nose

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. (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, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

LEADER

NDC: 70000-0246-1

COMPARE TO CHILDREN'S
BENADRYL® DYE-FREE active ingredient*

Children’s Dye-Free Allergy Relief

Diphenhydramine HCl ǀ Antihistamine
12.5 mg/5 mL Oral solution

Cherry Flavor

Sugar Free

Dye Free

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® Dye–Free.

IMPORTANT :

Keep this carton for the 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

INGREDIENTS AND APPEARANCE

CHILDRENS DYE FREE ALLERGY RELIEF 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0246
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
glycerin (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE (Clear, colorless)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0246-1	1 in 1 CARTON	05/02/2017
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 final	part341	05/02/2017

Labeler - CARDINAL HEALTH (097537435)