BENADRYL - diphenhydramine hydrochloride tablet, film coated
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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Benadryl®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 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
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing

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

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

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

Other information

each tablet contains: calcium 20 mg
store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect) or visit www.benadryl.com

PRINCIPAL DISPLAY PANEL

NDC 50580-226-52

Benadryl®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

ULTRATABS™*
*small tablet size

48 TABLETS

BENADRYL
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50580-226
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diphenhydramine Hydrochloride (Diphenhydramine)	Diphenhydramine Hydrochloride	25 mg

Ingredient Name	Strength
Inactive Ingredients
Carnauba Wax
Crospovidone
Croscarmellose Sodium
D&C Red no. 27
Aluminum Oxide
Calcium Phosphate, Dibasic, Dihydrate
Hypromelloses
Magnesium Stearate
Cellulose, Microcrystalline
Polyethylene Glycols
Polysorbate 80
Stearic Acid
Titanium Dioxide

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	B;WL;25
Contains

#	Item Code	Package Description
Packaging
1	NDC:50580-226-50	1 in 1 CARTON
1		100 in 1 BOTTLE
2	NDC:50580-226-51	2 in 1 CARTON
2		12 in 1 BLISTER PACK
3	NDC:50580-226-53	2 in 1 POUCH
4	NDC:50580-226-55	1 in 1 CARTON
4		148 in 1 BOTTLE
5	NDC:50580-226-52	4 in 1 CARTON
5		12 in 1 BLISTER PACK
6	NDC:50580-226-56	3 in 1 PACKAGE
6	NDC:50580-226-52	4 in 1 CARTON
6		12 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/01/2008

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

Revised: 6/2014

Document Id: 4f6aa85b-9a7e-4c25-8fb8-324307944f93

Set id: 702f9786-7ce9-43e4-921d-e1db09612127

Version: 4

Effective Time: 20140616

McNeil Consumer Healthcare Div McNeil-PPC, Inc