Kids-EEZE Cough and Cold

Dosage form: tablet, orally disintegrating
Ingredients: Dextromethorphan Hydrobromide 5mg, Phenylephrine Hydrochloride 2.5mg
Labeler: ProPhase Labs, Inc.
NDC Code: 61941-1003

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.

Kids-EEZE®
Cough
& Cold
Soft Chews
Great Tasting Grape

Drug Facts

Active ingredients (in each soft chew)Purposes
Dextromethorphan Hydrobromide 5mgCough Suppressant
Phenylephrine Hydrochloride 2.5mgNasal Decongestant

Uses

Temporarily

  • relieves cough and nasal congestion associated with a cold or hay fever
  • helps you cough less
  • controls the intensity of coughing
  • reduces the impulse to cough to help you sleep
  • relieves the cough impulses without narcotics
  • relieves stuffy nose and sinus congestion and pressure

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When using this product
  • do not exceed recommended dosage

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash, or persistent headache. These may be symptoms 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

  • Do not take more than 6 doses in 24 hours
adults and children 12 years and over4 chews every 4 hours
children 6 years to under 12 years2 chews every 4 hours
children under 6 years of ageask 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 acetate, croscarmellose sodium, D&C red # 27 aluminum lake, eudragit E acrylic polymer, FD&C blue #1 aluminum lake, fructose, flavors, hydroxypropylmethylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, 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 SOFT CHEW PACKAGE

NDC 61941-1003-6

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

Cough
&Cold

COUGH SUPPRESSANT • DEXTROMETHORPHAN HBr 5mg

NASAL DECONGESTANT • PHENYLEPHRINE HCl 2.5mg

For relief of:

+
Coughs
+
Stuffy Nose
+
Sinus
Congestion

Soft Chew

Great Tasting Grape

ARTIFICIALLY FLAVORED
12 SOFT CHEWS

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

KIDS-EEZE   COUGH AND COLD
dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CELLULOSE ACETATE 
FRUCTOSE 
MALIC ACID 
LECITHIN, SOYBEAN 
SODIUM CHLORIDE 
SODIUM LAURYL SULFATE 
XYLITOL 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize17mm
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61941-1003-172 PACKAGE (PACKAGE) in 1 CASE
1NDC:61941-1003-612 TABLET, ORALLY DISINTEGRATING (TABLET) 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/FEIOperations
ProPhase Labs, Inc.620557298LABEL, ANALYSIS
Establishment
NameAddressID/FEIOperations
Pharmaloz Manufacturing, Inc.067101998MANUFACTURE, ANALYSIS, PACK, REPACK

Revised: 04/2011
 
ProPhase Labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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