FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
Mylan Consumer Healthcare, Inc.
Effective date
2019-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:38:51

Label at a glance#

ProductCold-EEZE Homeopathic
Active ingredientZINC GLUCONATE, ROSA CANINA FRUIT, ECHINACEA PURPUREA
Label structure9 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 • supports immune system health*

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(per chewable gel)

Zinc Gluconate 1X HPUS† (8.8%) (13.2 mg zinc)

Rosa Canina (Rose Hips)
2X HPUS† (1.0%)

Echinacea Purpurea 1X HPUS† (0.02%)

† 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*

Promotes immune support*

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
  • supports immune system health*

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

SPL UNCLASSIFIED SECTION

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

Ask a doctor or pharmacist before use if you are

SPL UNCLASSIFIED SECTION

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

When using this product

SPL UNCLASSIFIED SECTION

Stop use and ask your doctor if

SPL UNCLASSIFIED SECTION

symptoms persist for more than 7 days

If pregnant or breast feeding,

SPL UNCLASSIFIED SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one chewable gel at onset of symptoms
  • chew slowly and dissolve completely in mouth before swallowing
  • do not swallow whole
  • do not eat or drink for 15 minutes after use
  • repeat every 2-4 hours until symptoms subside

Adults 18 years and over

do not exceed 6 chewable gels per day

Children 12 to under 18 years

do not exceed 4 chewable gels per day

Children under 12 years

ask a doctor before use

Other information

SPL UNCLASSIFIED SECTION

  • each chewable gel contains: sodium 10mg
  • store at room temperature in a cool, dry place
  • do not expose to excessive heat for long periods of time

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, flavors, glycine, malic acid, pectin, sambucus nigra (european elder),
sucrose, sugar, tricalcium phosphate, trisodium citrate dihydrate, water

Questions or comments?

SPL UNCLASSIFIED SECTION

Call 1-800-505-2653 (Monday-Friday: 8AM-5PM EST)

COLDEEZE® is a registered trademark
of Mylan Consumer Healthcare Inc.

Principal Display Panel – 25 Chewable Gels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-EEZE®

HOMEOPATHIC

SHORTENS YOUR COLD
Plus DEFENSE

  • Promotes
    Immune Health*

25 CHEWABLE GELS

Citrus
with
Elderberry
NATURAL FLAVOR

DO NOT USE IF SEAL UNDER CAP IS
BROKEN OR MISSING.

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

DISTRIBUTED BY:
MYLAN CONSUMER HEALTHCARE, INC.
MORGANTOWN, WV 26505 U.S.A.

Mylan.com

This product has not been
evaluated by the FDA.

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

NDC 46017-341-25      LB-34125-25-03

At the first sign of a cold, take one
chewable gel.

See Directions on other side of label.

Cold-Eeze Homeopathic Chewable Gels Bottle Label
Cold-Eeze Homeopathic Chewable Gels Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46017-34146017-341-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC GLUCONATEU6WSN5SQ1ZACTIB
ROSA CANINA FRUIT3TNW8D08V3ACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CORN SYRUP9G5L16BK6NIACT
GLYCINETE7660XO1CIACT
MALIC ACID817L1N4CKPIACT
PECTIN89NA02M4RXIACT
EUROPEAN ELDERBERRYBQY1UBX046IACT
SUCROSEC151H8M554IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

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
76efc45b-14da-4dc9-b497-20fcadf0cb453ae780a9-8ff7-4e01-897c-545526b3b6f92019-07-02WarningsExact identifier
spl id: 76efc45b-14da-4dc9-b497-20fcadf0cb45
spl set id: 3ae780a9-8ff7-4e01-897c-545526b3b6f9

Reported adverse events (FAERS/openFDA)#

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