Cold-EEZE

Manufacturer
Mylan Consumer Healthcare, Inc.
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:38:50

Label at a glance#

ProductCold-EEZE
Active ingredientZinc Gluconate
Label structure11 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 (13.3 mg Zinc) 

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, honey, 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)

*Based on unit sales of cold shortening, homeopathic zinc lozenges

+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.

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

Principal Display Panel – Honey Lemon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46017-321-83

The Original and #1 Best Selling Zinc Lozenges*

Cold-EEZE®
ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD
WORKS FASTER®+

CLINICALLY PROVEN
to reduce the duration of the common cold®

#1 PHARMACIST RECOMMENDED

18 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Honey Lemon

  • Take Cold-EEZE® when you have a cold+
  • Continue until symptoms are gone*
  • Gluten Free
  • Our clinically proven formula releases zinc ions in the mouth that shorten the duration of the common cold+
Cold-eeze Honey Lemon Flavored Carton
Cold-eeze Honey Lemon Flavored Carton

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46017-32146017-321-83, 46017-321-84, 46017-321-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
150f46d6-7bf5-4378-ac27-f484e739f4fb1e725505-d294-4da2-8f27-1039bbaffc992017-12-18WarningsExact identifier
spl id: 150f46d6-7bf5-4378-ac27-f484e739f4fb
spl set id: 1e725505-d294-4da2-8f27-1039bbaffc99

Reported adverse events (FAERS/openFDA)#

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