COMPLETE ALLERGY - diphenhydramine hydrochloride tablet
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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.

----------

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
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
ith any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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
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.

Directions

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 years of age

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

HEALTHCARE™

NDC 64092-830-24

Complete

Allergy

Antihistamine

Diphenhydramine HCl 25 mg

Relieves:

• Runny Nose •Sneezing

• Itchy Troat •Itchy, Watery Eyes

Easy-to-Swallow

*Compare to the active ingredient in

Benadryl® Allergy Ultratab™

24 MINITABS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

50844 REV0410E32908

Distributed by:

Great Lakes Wholesale & Marketing L.L.C.

3729 Patterson Ave., S.E.

Grand Rapids, MI 49512

Product Packaging

COMPLETE ALLERGY
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64092-830
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
CELLULOSE, MICROCRYSTALLINE
D&C RED NO. 27
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	PINK	Score	no score
Shape	CLOVER	Size	11mm
Flavor		Imprint Code	44;329
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:64092-830-08	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		24 TABLET (24 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (64092-830-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/02/1990

Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Revised: 07/2011 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.