COLD-EEZE- zinc gluconate lozenge 
Mylan Consumer Healthcare, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Drug Facts

Active ingredient (per lozenge)

Zinc Gluconate 2X HPUS† (2.3%) (13.3 mg zinc)

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

Purpose

Cold Remedy

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

Warnings

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

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

Stop use and ask your doctor if symptoms persist more than 7 days.

If pregnant or breastfeeding,

ask a healthcare professional before use. 

Keep out of reach of children.

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

Directions

•
take one lozenge at the onset of symptoms
•
dissolve entire lozenge in mouth
•
do not chew
•
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 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

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

Inactive ingredients

corn syrup, glycine, natural flavors and sucrose.

Questions or comments?

call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)

 

*A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed.

The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal.

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

‡Based on unit sales of cold shortening, homeopathic zinc lozenges.

This product has not been evaluated by the FDA.

UC-32025-25-00

©2020 Mylan Inc.

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

Mylan.com

Principal Display Panel – Cherry Lozenges

NDC 46017-320-25

The #1 Best Selling Zinc Lozenge Brand‡

Cold-EEZE®
COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD®

CLINICALLY TESTED
to Shorten Colds by 42%*

PHARMACIST
Recommended

25 Lozenges

NATURAL
CHERRY FLAVOR

✓
Our clinically tested
formula releases
zinc ions in the mouth®
and shortens the
duration of the
common cold
✓
Take Cold-EEZE® at
the first sign of a cold
✓
Continue until
symptoms are gone
✓
Gluten Free
✓
No artificial colors
or preservatives
Cold-EEZE Cherry Carton

Principal Display Panel – Orange

NDC 46017-325-97

+SHORTENS YOUR COLD

Cold-EEZE®
Zinc Gluconate Glycine

+
Clinically proven to reduce the duration of the common cold®
+
#1 Pharmacist Recommended
+
Shortens your cold, works faster®

10 Cold Remedy
Lozenges
Homeopathic

All Natural
Tropical Orange Flavor

+
Take Cold-EEZE® when you have a cold
+
Continue until symptoms are gone
+
Our clinically proven formula releases zinc ions in the mouth that shorten the duration of the common cold
Cold-EEZE Orange Carton

Principal Display Panel – Strawberries and Cream

NDC 46017-327-83

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
Strawberries
and Cream

+
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 Strawberries and Cream Flavored Carton
COLD-EEZE 
zinc gluconate lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Corn Syrup (UNII: 9G5L16BK6N)  
Glycine (UNII: TE7660XO1C)  
Sucrose (UNII: C151H8M554)  
Product Characteristics
ColorWHITE (semi-translucent) Scoreno score
ShapeOVALSize23mm
FlavorCHERRYImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-320-251 in 1 BOX06/12/202010/31/2022
125 in 1 BAG; Type 0: Not a Combination Product
2NDC:46017-320-971 in 1 BOX05/07/201810/31/2022
210 in 1 BAG; Type 0: Not a Combination Product
3NDC:46017-320-831 in 1 BOX05/29/201810/31/2022
318 in 1 BAG; Type 0: Not a Combination Product
4NDC:46017-320-8418 in 1 BAG; Type 0: Not a Combination Product08/22/201810/31/2022
5NDC:46017-320-441 in 1 BOX10/19/201810/31/2022
524 in 1 BAG; Type 0: Not a Combination Product
6NDC:46017-320-901 in 1 BOX02/08/201910/31/2022
62 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic05/07/201810/31/2022
COLD-EEZE 
zinc gluconate lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Corn Syrup (UNII: 9G5L16BK6N)  
Glycine (UNII: TE7660XO1C)  
Sucrose (UNII: C151H8M554)  
Product Characteristics
ColorWHITE (semi-translucent) Scoreno score
ShapeOVALSize23mm
FlavorORANGE (tropical orange) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-325-831 in 1 BOX10/15/201810/31/2022
118 in 1 BAG; Type 0: Not a Combination Product
2NDC:46017-325-8418 in 1 BAG; Type 0: Not a Combination Product08/22/201810/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic05/07/201810/31/2022
COLD-EEZE 
zinc gluconate lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Corn Syrup (UNII: 9G5L16BK6N)  
Glycine (UNII: TE7660XO1C)  
Sucrose (UNII: C151H8M554)  
Product Characteristics
ColorWHITE (semi-translucent) Scoreno score
ShapeOVALSize23mm
FlavorSTRAWBERRY (strawberries and cream) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-327-831 in 1 BOX05/07/2023
118 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic05/07/201810/31/2022
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 10/2020
Document Id: dd5afd57-2f8a-46f3-8c7c-20c86fd13bdb
Set id: feeedd57-d6b9-411f-8f29-1dbcc95a6fba
Version: 11
Effective Time: 20201029
 
Mylan Consumer Healthcare, Inc.