FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
Mylan Consumer Healthcare, Inc.
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:38:48

Label at a glance#

ProductCold-EEZE Plus Defense
Active ingredientZinc Gluconate, Sambucus Nigra Flower, ROSA CANINA LEAF, ECHINACEA PURPUREA, AVENA SATIVA LEAF
Label structure17 sections

Indications and uses

• reduces the duration of the common cold • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness • supports immune system health* • helps with a general debility and fatigue*

Dosage and administration

• take one at the onset of symptoms • do not swallow whole • dissolve entire lozenge in mouth • do not eat or drink for 15 minutes after use • do not chew • repeat every 2-4 hours until symptoms subside Adults 18 years and over do not exceed 6 lozenges per day Children 12 to under 18 years do not exceed 4 lozenges per day Children under 12 years ask a doctor before use

Label contents#

Full prescribing information#

Active Ingredients (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zinc Gluconate 1X HPUS† (2.22%) (13.3 mg zinc)
Sambucus Nigra 1X HPUS† (1.11%)
Avena Sativa L. 2X HPUS† (0.14%)
Rosa Canina (Rose Hips) 2X HPUS† (0.09%)
Echinacea Purpurea 3X HPUS† (0.04%)

†The letters ‘HPUS’ indicates that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purposes

OTC - PURPOSE SECTION

Cold Remedy
Promotes immune support*
Helps with general debility and fatigue*
Promotes immune support*
Promotes immune support*

Uses

INDICATIONS & USAGE SECTION

  • reduces the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
  • supports immune system health*
  • helps with a general debility and fatigue*

Warnings

WARNINGS SECTION

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • diabetes
  • multiple sclerosis (MS)
  • rheumatoid arthritis (RA) or other auto-immune condition

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When using this product

OTC - WHEN USING SECTION

do not take on an empty stomach (to avoid possible minor stomach upset).

Stop use and ask your healthcare practitioner if

OTC - STOP USE SECTION

symptoms persist beyond 7 days.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one at the onset of symptoms
  • do not swallow whole
  • dissolve entire lozenge in mouth
  • do not eat or drink for 15 minutes after use
  • do not chew
  • repeat every 2-4 hours until symptoms subside

Adults 18 years and over

do not exceed 6 lozenges per day

Children 12 to under 18 years

do not exceed 4 lozenges per day

Children under 12 years

ask a doctor before use

Other information

OTHER SAFETY INFORMATION

  • store in a cool, dry place after opening
  • best if used within 6 months after opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn syrup, glycine, natural colors, natural flavors and sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-505-2653 (Monday-Friday: 8am-5pm EST)

SPL UNCLASSIFIED SECTION

This product has not been evaluated by the FDA.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

No artificial colors or preservatives

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

Principal Display Panel – Citrus with Elderberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46017-323-25

The #1 Best Selling Zinc Lozenge Brand‡

Cold-EEZE®
COLD REMEDY

HOMEOPATHIC

SHORTENS YOUR COLD®

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

25
Lozenges

NATURAL FLAVOR
CITRUS WITH ELDERBERRY

  • Shortens your cold
  • Promotes Immune Health*
  • Helps with Fatigue*
  • No artificial colors or preservatives

Learn more about Cold-EEZE®
at www.coldeeze.com

  • Releases zinc ions in the mouth® and shortens the duration of the common cold
  • Pharmacist recommended zinc lozenge brand

UC-32325-25-02

©2020 Mylan Inc.

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

Mylan.com

Cold-EEZE Plus Defense Carton Label Citrus with Elderberry
Cold-EEZE Plus Defense Carton Label Citrus with Elderberry

Principal Display Panel – Manuka Honey Lemon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46017-342-25

The #1 Best Selling Zinc Lozenge Brand‡

Cold-EEZE®
COLD REMEDY

HOMEOPATHIC

SHORTENS YOUR COLD®

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

25
Lozenges

NATURAL FLAVOR
MANUKA HONEY LEMON

  • Shortens your cold
  • Promotes Immune Health*
  • Helps with Fatigue*
  • No artificial colors or preservatives

Learn more about Cold-EEZE®
at www.coldeeze.com

  • Releases zinc ions in the mouth® and shortens the duration of the common cold
  • Pharmacist recommended zinc lozenge brand

UC-34225-25-03

©2020 Mylan Inc.

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

Mylan.com

Cold-EEZE Plus Defense Carton Label Manuka Honey Lemon
Cold-EEZE Plus Defense Carton Label Manuka Honey Lemon

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46017-32346017-323-25, 46017-323-96, 46017-323-95, 46017-323-90
46017-34246017-342-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc GluconateU6WSN5SQ1ZACTIB
Sambucus Nigra Flower07V4DX094TACTIB
ROSA CANINA LEAFJ3N2Z889QPACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
AVENA SATIVA LEAF206PI19V7RACTIB
Corn Syrup9G5L16BK6NIACT
GlycineTE7660XO1CIACT
SucroseC151H8M554IACT
Zinc GluconateU6WSN5SQ1ZACTIB
Sambucus Nigra Flower07V4DX094TACTIB
ROSA CANINA LEAFJ3N2Z889QPACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
AVENA SATIVA LEAF206PI19V7RACTIB
Corn Syrup9G5L16BK6NIACT
GlycineTE7660XO1CIACT
SucroseC151H8M554IACT

Source Document#

Source XML · Source PDF

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
22e6e065-803a-4c8f-ab34-b59149e65bed035587ba-b51f-4328-83a8-0ae2ea2c51112020-10-29WarningsExact identifier
spl id: 22e6e065-803a-4c8f-ab34-b59149e65bed
spl set id: 035587ba-b51f-4328-83a8-0ae2ea2c5111

Reported adverse events (FAERS/openFDA)#

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