KIDS-EEZE  CHEST RELIEF- guaifenesin 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®
Chest Relief

Drug Facts

Active ingredient (in each soft chew)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Ask a doctor before use if you have

  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

Other information

Inactive ingredients

croscarmelose sodium, ethylcellulose, FD&C red #40 lake, ethylene glycol & vinyl alcohol graft copolymer, malic acid, methacrylic copolymer, monoammonium glycyrrhizinate, non fat dry milk, octaglycerol monooleate emulsifier, vegetable oil, polysorbate 80, salt, silicon dioxide, sodium starch glycolate, soy lecithin, strawberry flavors, sucralose, sugar, vanilla flavor

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

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton

NDC 61941-1002-6

Kids-EEZE®

From The Makers Of
Cold-EEZE®

Chest
Relief

EXPECTORANT • GUAIFENESIN 100 mg

+
Relieves Chest
Congestion
+
Thins &
Loosens
Mucus

Soft Chew

Great Tasting
Strawberry

ARTIFICIALLY FLAVORED
12 SOFT CHEWS

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

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton
KIDS-EEZE   CHEST RELIEF
guaifenesin tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)  
ETHYLENE GLYCOL (UNII: FC72KVT52F)  
MALIC ACID (UNII: 817L1N4CKP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize23mm
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61941-1002-172 in 1 CASE
1NDC:61941-1002-612 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2008
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: 4f391211-f806-4c0f-887b-d32759754a49
Set id: 6f2276fb-7a69-4aae-87f4-8c78e71bfa7b
Version: 1
Effective Time: 20110401
 
ProPhase Labs, Inc.