CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride liquid
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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.

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Children's
Benadryl®
ALLERGY

Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon

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 you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

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
do not take more than 6 doses in 24 hours

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	1 to 2 pre-filled spoons
adults and children 12 years and over	2 to 4 pre-filled spoons

Other information

each pre-filled spoon contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
SAFETY SEALED: This product is protected by sealed pouches. Do not use if individual pouches are torn or damaged
see side panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NDC 50580-334-10

THE HISTAMINE BLOCKER™
children's
Benadryl®

ALLERGY
Diphenhydramine HCI oral solution
Antihistamine

Perfect Measure®

RELIEVES

✔: Sneezing
✔: Runny Nose
✔: Itchy, Watery Eyes
✔: Itchy Throat

ON-THE-GO
ALLERGY RELIEF

10
PRE-FILLED SINGLE USE SPOONS*
0.17 FL OZ (5 mL) EACH
*12.5 mg Diphenhydramine HCl each

Cherry
FLAVORED LIQUID
Alcohol Free

CHILDRENS BENADRYL ALLERGY
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50580-334
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diphenhydramine Hydrochloride (Diphenhydramine)	Diphenhydramine Hydrochloride	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
anhydrous citric acid
D&C red NO. 33
FD&C red NO. 40
glycerin
glycyrrhizin, ammoniated
poloxamer 407
water
sodium benzoate
sodium chloride
sodium citrate
sucrose

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:50580-334-10	10 in 1 CARTON
1		5 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/01/2008

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 4/2011

Document Id: 79b51520-ca43-4aae-85cd-75b4dfd6dceb

Set id: c2e9aecd-6478-4f7b-a90a-f14090af0bd4

Version: 1

Effective Time: 20110422

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Children's Benadryl® ALLERGY