KIDS-EEZE  ALLERGY- diphenhydramine hydrochloride tablet, orally disintegrating 
ProPhase Labs, 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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Kids-EEZE®
Allergy
Soft Chews
Great Tasting Grape

Drug Facts

Active ingredient (in each soft chew)

Diphenhydramine Hydrochloride 12.5mg

Purpose

Antihistamine

Uses

For the temporary relief of

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

adults and children 12 years and over2 to 4 chews every 4 to 6 hours
children 6 years to under 12 years1 to 2 chews every 4 to 6 hours
children under 6 years of ageask a doctor

Other information

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

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

Principal Display Panel - 12.5 mg Package
KIDS-EEZE   ALLERGY
diphenhydramine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScoreno score
ShapeOVALSize17mm
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61941-1005-172 in 1 CASE
1NDC:61941-1005-612 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2010
Labeler - ProPhase Labs, Inc. (620557298)
Establishment
NameAddressID/FEIBusiness Operations
ProPhase Labs, Inc.620557298LABEL, ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Pharmaloz Manufacturing, Inc.067101998MANUFACTURE, ANALYSIS, PACK, REPACK

Revised: 4/2011
Document Id: 185301e7-69c9-43ef-93c1-e6dddeb153ad
Set id: cf4f599c-f3b2-4e07-8157-1486094ee52b
Version: 1
Effective Time: 20110401
 
ProPhase Labs, Inc.