Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2011-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:10

Label at a glance#

ProductCold-EEZE
Active ingredientZinc Gluconate
Label structure15 sections

Indications and 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

Dosage and administration

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

Storage and handling

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 product may produce a laxative effect

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 2x (13.3mg)

Purpose

OTC - PURPOSE SECTION

Cold Remedy

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

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

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

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

WARNINGS SECTION

Diabetic Warning: sugar replacements may affect blood sugar levels.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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
  • product may produce a laxative effect

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame-K, glycine, Isomalt, natural flavors. No artificial colors or preservatives.

Questions or Comments:

OTC - QUESTIONS SECTION

Call 1-800-505-COLD
(9AM-5PM EST)

PRINCIPAL DISPLAY PANEL - 18 Lozenge Wild Cherry Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

18
Cold Remedy
Lozenges

Homeopathic

All Natural
Wild Cherry Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Lozenge Wild Cherry Carton
PRINCIPAL DISPLAY PANEL - 18 Lozenge Wild Cherry Carton

PRINCIPAL DISPLAY PANEL - 24 Lozenge Wild Cherry Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

24
Cold Remedy
Lozenges

Homeopathic

All Natural
Wild Cherry Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Lozenge Wild Cherry Carton
PRINCIPAL DISPLAY PANEL - 24 Lozenge Wild Cherry Carton

PRINCIPAL DISPLAY PANEL - 18 Lozenge Honey Lemon Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

18
Cold Remedy
Lozenges

Homeopathic

All Natural
Honey Lemon Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Lozenge Honey Lemon Carton
PRINCIPAL DISPLAY PANEL - 18 Lozenge Honey Lemon Carton

PRINCIPAL DISPLAY PANEL - 24 Lozenge Honey Lemon Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

24
Cold Remedy
Lozenges

Homeopathic

All Natural
Honey Lemon Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Lozenge Honey Lemon Carton
PRINCIPAL DISPLAY PANEL - 24 Lozenge Honey Lemon Carton

PRINCIPAL DISPLAY PANEL - 18 Lozenge Pomegranate Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

18
Cold Remedy
Lozenges

Homeopathic

All Natural
Pomegranate Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Lozenge Pomegranate Carton
PRINCIPAL DISPLAY PANEL - 18 Lozenge Pomegranate Carton

PRINCIPAL DISPLAY PANEL - 24 Lozenge Pomegranate Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

  • Clinically proven to reduce the
    duration of the common cold ®
  • #1 Pharmacist Recommended
  • Shortens your cold, works fast

24
Cold Remedy
Lozenges

Homeopathic

All Natural
Pomegranate Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Lozenge Pomegranate Carton
PRINCIPAL DISPLAY PANEL - 24 Lozenge Pomegranate Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0081-12020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0081-22020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0081-32020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0082-42020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0091-12020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0091-22020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0091-32020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0092-42020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0101-12020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0101-22020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0101-32020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY
61941-0102-42020-01-31C16284748780-19d75b9d0-5056-f424-e053-dadaa90a57ceCold-EEZE ® Zinc Gluconate Glycine COLD REMEDY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0081-1Cold-EEZE24 in 1 CASELOZENGE241
61941-0081-2Cold-EEZE48 in 1 CASELOZENGE481
61941-0081-3Cold-EEZE144 in 1 CASELOZENGE1441
61941-0081-8Cold-EEZE18 in 1 PACKAGELOZENGE181
61941-0082-4Cold-EEZE24 in 1 PACKAGELOZENGE241
61941-0091-1Cold-EEZE24 in 1 CASELOZENGE241
61941-0091-2Cold-EEZE48 in 1 CASELOZENGE481
61941-0091-3Cold-EEZE144 in 1 CASELOZENGE1441
61941-0091-8Cold-EEZE18 in 1 PACKAGELOZENGE181
61941-0092-4Cold-EEZE24 in 1 PACKAGELOZENGE241
61941-0101-1Cold-EEZE24 in 1 CASELOZENGE241
61941-0101-2Cold-EEZE48 in 1 CASELOZENGE481
61941-0101-3Cold-EEZE144 in 1 CASELOZENGE1441
61941-0101-8Cold-EEZE18 in 1 PACKAGELOZENGE181
61941-0102-4Cold-EEZE24 in 1 PACKAGELOZENGE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0081COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 4 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip
61941-0082COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip
61941-0091COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 4 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip
61941-0092COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip
61941-0101COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 4 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip
61941-0102COLD-EEZE (ZINC GLUCONATE) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20110531_58123f25-56d8-4b29-83fd-ca4981a38c08.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc GluconateACTIVE INGREDIENTU6WSN5SQ1Z1
ZincACTIVE MOIETYJ41CSQ7QDS1
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G91
GlycineINACTIVE INGREDIENTTE7660XO1C1
IsomaltINACTIVE INGREDIENTS870P55O2W1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9FILM, SOLUBLE / ORAL10 mgExact identifier — unii candidate
17 equally ranked IID candidates
IsomaltISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii candidate
5 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9GUM, CHEWING / BUCCAL147 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9FILM / SUBLINGUAL5 mgExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CCAPSULE, DELAYED RELEASE / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET / SUBLINGUAL13 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CSOLUTION / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii candidate
17 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9SOLUTION / DENTAL0.12 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPOWDER, FOR SOLUTION / ORAL0.09 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii candidate
17 equally ranked IID candidates
IsomaltISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii candidate
5 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
IsomaltISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii candidate
5 equally ranked IID candidates
GlycineGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPASTE, DENTIFRICE / DENTAL0.34 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION / INTRAMUSCULAR68 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CTABLET / ORAL163.31 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3.76 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii candidate
17 equally ranked IID candidates
IsomaltISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii candidate
5 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
IsomaltISOMALTS870P55O2WPOWDER / SUBLINGUAL530 mgExact identifier — unii candidate
5 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9SUSPENSION / ORAL160 mgExact identifier — unii candidate
17 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28f7f321-29f9-4a2e-a21f-6d2420eb755c58123f25-56d8-4b29-83fd-ca4981a38c082011-03-30WarningsExact identifier
spl id: 28f7f321-29f9-4a2e-a21f-6d2420eb755c
spl set id: 58123f25-56d8-4b29-83fd-ca4981a38c08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.