ANTIHISTIMINE ALLERGY - diphenhydramine hydrochloride tablet
P and L Development of New York Company

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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Active Ingredients (in each tablet)

Diphenhydramine HCl 25mg

Purpose

Antihistimine

Uses

Enter section text here

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)

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age    1 tablet
children under 6 years of age        do not use this product in children under 6
children under 4 years of age    do not use

each tablet contains: calcium 25 mg/tablet

store at room temperature 15°-30°C (59°-86°F)

protect from light and moisture

do not use if imprinted safety seal under cap is broken or missing

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy ULTRATAB

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red No. 27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients

Questions or Comments

Call toll free 1-877-753-3935 Monday through Friday 9AM – 5PM EST

Distributed by:
PL Developments
Westbury, NY 11590, USA

Package Label

NDC 59726-690-01

*Compare to the active ingredient in
Benadryl® Allergy ULTRATAB®

Antihistimine Allergy Tablets
Diphenhydramine Hydrochloride 25mg

For Allergy Relief
Sneezing, Itchy, Watery Eyes
Runny Nose, Itchy Throat

100 tablets

Product Bottle Label

Diphenhydramine Hydrochloride

ANTIHISTIMINE ALLERGY
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59726-690
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
ALUMINUM OXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POLYVINYL ALCOHOL
WATER
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	pink (PINK)	Score	no score
Shape	OVAL (OVAL)	Size	6mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59726-690-01	1 BOTTLE ( BOTTLE) in 1 BOX	contains a BOTTLE
1		100 TABLET ( TABLET) in 1 BOTTLE	This package is contained within the BOX (59726-690-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/08/2011

Labeler - P and L Development of New York Company (800014821)

Revised: 12/2011 P and L Development of New York Company