Cold-EEZE

Manufacturer
Mylan Consumer Healthcare, Inc.
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:38:57

Label at a glance#

ProductCold-EEZE Plus Natural Multi-Symptom Relief
Active ingredientZinc Gluconate, Sambucus Nigra Flower, GLYCYRRHIZA GLABRA LEAF
Label structure15 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 • temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with colds and flu*

Dosage and administration

• take one lozenge 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 Ingredient (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc)
Sambucus Nigra 2X HPUS† (1.0%)
Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)

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

Purpose

OTC - PURPOSE SECTION

Cold Remedy
relieves cough, nasal congestion and irritated respiratory tract*
relieves irritated throat*

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
  • temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with colds and flu*

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 provide relief of cold and flu 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 doctor if

OTC - STOP USE SECTION

symptoms persist beyond 7 days

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare practitioner before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one lozenge 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

‡Based on the Cold-EEZE brand unit sales of cold shortening, homeopathic zinc lozenges.

©2019 Mylan Inc.

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

This product has no expiration date

Principal Display Panel – Mixed Berry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46017-322-96

Cold-EEZE
HOMEOPATHIC

SHORTENS YOUR COLD

Plus Natural
Multi-Symtpom Relief*
Cold & Flu

12 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Mixed Berry

  • Shortens your cold
  • Also helps relieve:
    • Cough*
    • Congestion*
    • Sore Throat*
  • Gluten Free
  • Releases zinc ions in the mouth®
  • #1 pharmacist recommended zinc lozenge brand
Cold-EEZE Plus Natural Carton Label
Cold-EEZE Plus Natural Carton Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46017-32246017-322-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
5076cb25-6b6a-4354-8cb8-c33f6686261df65c143a-47ec-4939-813b-2d31d3294fd32017-12-18WarningsExact identifier
spl id: 5076cb25-6b6a-4354-8cb8-c33f6686261d
spl set id: f65c143a-47ec-4939-813b-2d31d3294fd3

Reported adverse events (FAERS/openFDA)#

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