Label: KIDS-EEZE- dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-1003-1, 61941-1003-6 - Packager: ProPhase Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
- Directions
- Other information
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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
- QUESTIONS
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PRINCIPAL DISPLAY PANEL - 12 SOFT CHEW PACKAGE
NDC 61941-1003-6
Kids-EEZE®
From The Makers Of
Cold-EEZE®Cough
&ColdCOUGH SUPPRESSANT • DEXTROMETHORPHAN HBr 5mg
NASAL DECONGESTANT • PHENYLEPHRINE HCl 2.5mg
For relief of:
- +
- Coughs
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- Stuffy Nose
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- Sinus
Congestion
Soft Chew
Great Tasting Grape
ARTIFICIALLY FLAVORED
12 SOFT CHEWSTAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open
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INGREDIENTS AND APPEARANCE
KIDS-EEZE COUGH AND COLD
dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-1003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE ACETATE (UNII: 3J2P07GVB6) FRUCTOSE (UNII: 6YSS42VSEV) MALIC ACID (UNII: 817L1N4CKP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XYLITOL (UNII: VCQ006KQ1E) 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:61941-1003-1 72 in 1 CASE 1 NDC:61941-1003-6 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