Your browser does not support JavaScript! COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]
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COLD-EEZE (zinc gluconate) lozenge
[ProPhase Labs, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved homeopathic
NOTE:THIS HOMEOPATHIC PRODUCT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION FOR SAFETY OR EFFICACY. FDA IS NOT AWARE OF SCIENTIFIC EVIDENCE TO SUPPORT HOMEOPATHY AS EFFECTIVE.
Drug Label Sections

Drug Facts

Active ingredient (per lozenge)

Zincum Gluconicum 2x (13.3mg)

Purpose

Homeopathic Cold Remedy

Uses

  • to reduce the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

Warnings

Ask a doctor before use if you

  • are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • children under 12 years of age should consult a health professional prior to use

Other information

  • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids

  • store in a cool dry place after opening

  • gluten-free

Inactive ingredients

corn syrup, honey, glycine, lemon oil, natural green tea flavor and sucrose. No artificial colors or preservatives.

QUESTIONS? COMMENTS?

CALL 1-800-505-COLD
9am - 5pm Eastern

PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton

Shorten your cold!
Get better faster!

Quigley

Homeopathic
Cold-EEZE®

Clinically proven to
reduce the duration
of the common cold

Zinc
Gluconate
Glycine

PHARMACIST
RECOMMENDED

#1
ACHIEVEMENT
AWARD

18
Cold Remedy
Lozenges

Natural Green Tea
with Honey Flavor
with other natural flavors

Principal Display Panel - 18 Lozenge Carton
COLD-EEZE  
zinc gluconate lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61941-0111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (Zinc) Zinc Gluconate2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Corn Syrup 
Glycine 
Sucrose 
Product Characteristics
ColorWHITE (Semi-Translucent) Scoreno score
ShapeOVALSize23mm
FlavorFIG (Green Tea) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61941-0111-124 in 1 CASE
1NDC:61941-0111-818 in 1 PACKAGE
2NDC:61941-0111-248 in 1 CASE
2NDC:61941-0111-818 in 1 PACKAGE
3NDC:61941-0111-3144 in 1 CASE
3NDC:61941-0111-818 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC02/01/2003
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
 
ProPhase Labs, Inc.

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