BENADRYL - diphenhydramine hydrochloride tablet, film coated
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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Benadryl®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

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 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
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 this product in children under 6 years of age

Other information

each tablet contains: calcium 15 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
see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, crospovidone, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NEW
LOOK!
SAME RELIEF

NDC 50580-226-24

Benadryl®

ALLERGY

Diphenhydramine HCl | Antihistamine

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

24
ULTRATAB™* TABLETS 25 MG EACH
*small tablet size

Principal Display Panel - 24 Tablets Carton

BENADRYL
diphenhydramine hydrochloride tablet, film coated

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

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

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

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

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50580-226-02	60 POUCH In 1 CARTON	contains a POUCH
1		2 TABLET In 1 POUCH	This package is contained within the CARTON (50580-226-02)
2	50580-226-10	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		100 TABLET In 1 BOTTLE	This package is contained within the CARTON (50580-226-10)
3	50580-226-11	1 BOTTLE In 1 CARTON	contains a BOTTLE
3		100 TABLET In 1 BOTTLE	This package is contained within the CARTON (50580-226-11)
4	50580-226-14	1 BOTTLE In 1 CARTON	contains a BOTTLE
4		148 TABLET In 1 BOTTLE	This package is contained within the CARTON (50580-226-14)
5	50580-226-24	2 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
5		12 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50580-226-24)
6	50580-226-48	4 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
6		12 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50580-226-48)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part342	09/01/2008

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

Revised: 09/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc