KIDS-EEZE- diphenhydramine hydrochloride tablet, orally disintegrating

Kids-EEZE by

Drug Labeling and Warnings

Kids-EEZE by is a Otc medication manufactured, distributed, or labeled by ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each soft chew)

Diphenhydramine Hydrochloride 12.5mg

Purpose

Antihistamine

Uses

For the temporary relief of

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on the skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

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

When using this product

• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages while taking this product
• use caution 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.

Directions

Chew and swallow as directed below

• Do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2 to 4 chews every 4 to 6 hours
• children 6 years to under 12 years: 1 to 2 chews every 4 to 6 hours
• children under 6 years of age: ask a doctor

Other information

• each soft chew contains 6 mg sodium
• tamper evident: do not use if inner blister pack is torn or open
• store at controlled room temperature 15-30°C (59-86°F)

Inactive ingredients

ammonium glycyrrhizinate, cellulose, croscarmellose sodium, D&C red #27 lake, ethylcellulose, FD&C blue #1 lake, fructose, flavors, hydroxypropylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sucralose, sugar, vegetable oil, xylitol

QUESTIONS

To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)

PRINCIPAL DISPLAY PANEL - 12.5 mg Package

NDC: 61941-1005-6

Kids-EEZE®
From The Makers Of
Cold-EEZE®

Allergy

ANTIHISTAMINE DIPHENHYDRAMINE HCl 12.5mg
Due to hay fever or upper respiratory allergies

For relief of:

+ Runny Nose
+ Sneezing
+ Itchy Watery
Eyes
+ Itchy
Throat

Soft Chew

Great Tasting Grape

ARTIFICIALLY FLAVORED
12 SOFT CHEWS

TAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open

INGREDIENTS AND APPEARANCE

KIDS-EEZE   ALLERGY
diphenhydramine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-1005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)
FRUCTOSE (UNII: 6YSS42VSEV)
MALIC ACID (UNII: 817L1N4CKP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	17mm
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-1005-1	72 in 1 CASE
1	NDC: 61941-1005-6	12 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2010

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL, ANALYSIS

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE, ANALYSIS, PACK, REPACK