Cold-EEZE

Manufacturer
A-S Medication Solutions
Effective date
2019-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:01

Label at a glance#

ProductCold-EEZE
Active ingredientZINC GLUCONATE
Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years and over: • take Cold-EEZE ® when you have cold symptoms • completely dissolve a Cold-EEZE ® lozenge in mouth (do not chew) • repeat every 2 - 4 hours as needed until all symptoms subside • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12 - 17 Children under 12 years of age should consult a healthcare practitioner prior to use

Label contents#

Full prescribing information#

Active ingredient (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 2x 

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, nasal congestion, post nasal drip and/or hoarseness

Warnings

WARNINGS 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

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

Cold-EEZE® lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare practitioner before use. 

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

  • take Cold-EEZE® when you have cold symptoms
  • completely dissolve a Cold-EEZE® lozenge in mouth (do not chew)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12 - 17

Children under 12 years of age should consult a healthcare practitioner prior to use

Other information

OTHER SAFETY INFORMATION

  • do not take Cold-EEZE® lozenges on an empty stomach to avoid possible minor stomach upset
  • do not eat or drink for 15 minutes after use
  • store in a cool, dry place after opening; best if used within 6 months after opening
  • gluten free

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn syrup, glycine, natural flavors and sucrose.

No artificial colors or preservatives.

 

SPL UNCLASSIFIED SECTION

Clinical Studies have shown: The unique Cold-EEZE® formula reduces the duration of the common cold by almost half.

The double blind placebo controlled studies were conducted at the Cleveland Clinic and Dartmouth College and published in peer reviewed journals.

Cold-EEZE® is safe to take with most other medications and is gluten free. (see warnings)

Does Not Cause Drowsiness

Does Not Cause Light Headedness

Does Not Affect Blood Pressure

For cold-fighting tips and more about the Cold-EEZE® science, go to www.ColdEEZE.com

Questions or Comments:

OTC - QUESTIONS SECTION

Call 1-800-505-2653
(M-F: 8AM-5PM ET)

Mylan.com

Manufactured for:
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 U.S.A.

+THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

This product has no expiration date.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4156

NDC: 50090-4156-0 18 LOZENGE in a BAG / 1 in a BOX

Zinc Gluconate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4156-02023-01-30C16284748780-1f386c649-a188-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4156-0Cold-EEZE1 in 1 BOXLOZENGE11
50090-4156-0Cold-EEZE18 in 1 BAGLOZENGE181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4156COLD-EEZE (ZINC GLUCONATE) LOZENGE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20190305_c64d5ac7-9c30-4a67-8b70-11a54fcc46c5.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-415650090-4156-0
46017-320

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

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
1a501991-8c39-4300-9b63-e1879fedde21c64d5ac7-9c30-4a67-8b70-11a54fcc46c52019-02-27WarningsExact identifier
spl id: 1a501991-8c39-4300-9b63-e1879fedde21
spl set id: c64d5ac7-9c30-4a67-8b70-11a54fcc46c5

Reported adverse events (FAERS/openFDA)#

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