Drug Facts

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

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
mL = milliliter
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours

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

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

Other information

each 5 mL contains: sodium 10 mg
store between 20-25°C (68-77°F)
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

call 1-877-717-2824 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-535-01

Children's
Benadryl ®

DYE-FREE ALLERGY

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

Runny Nose
Sneezing
Itchy,Watery Eyes
Itchy Throat or Nose

✔ Free Of:

Dyes
Alcohol
Sugar
Parabens
High Fructose
Corn Syrup

Bubble Gum!
Flavored Liquid

4 fl oz (118 mL)

CHILDRENS BENADRYL DYE-FREE ALLERGY
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-535
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	white (Clear, colorless)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50580-535-01	1 in 1 CARTON	12/01/2015
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC:50580-535-08	1 in 1 CARTON	06/16/2022
2		236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	07/01/2008

Labeler - Johnson & Johnson Consumer Inc. (878046358)

Children's Benadryl ® DYE-FREE ALLERGY