COLD-EEZE- zinc gluconate lozenge

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Homeopathic medication manufactured, distributed, or labeled by Mylan Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per lozenge)

Zincum Gluconicum 2x (13.3 mg Zinc) 

Purpose

Cold Remedy

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

Warnings

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.

Diabetic Warning: sugar replacements may affect blood sugar levels.

If pregnant or breastfeeding,

ask a healthcare practitioner before use. 

Keep out of reach of children.

Directions

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

• 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
• product may produce a laxative effect

Inactive ingredients

Acesulfame-K, glycine, Isomalt, natural flavors. No artificial colors or preservatives.

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:

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 – Sugar Free Cherry Lozenges

NDC: 46017-324-83

The Original and #1 Best Selling Zinc Lozenges*

Cold-EEZE®
ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD
WORKS FASTER®+

SUGAR FREE

CLINICALLY PROVEN
to reduce the duration of the common cold®+

#1 PHARMACIST RECOMMENDED

18 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Sugar Free
Wild Cherry

• + 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+

Principal Display Panel – Sugar Free Honey Lemon

NDC: 46017-334-83

The Original and #1 Best Selling Zinc Lozenges*

Cold-EEZE®
ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD
WORKS FASTER®+

SUGAR FREE

CLINICALLY PROVEN
to reduce the duration of the common cold®+

#1 PHARMACIST RECOMMENDED

18 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Sugar Free
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+

Principal Display Panel – Sugar Free Pomegranate

NDC: 46017-335-83

The Original and #1 Best Selling Zinc Lozenges*

Cold-EEZE®
ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD
WORKS FASTER®+

SUGAR FREE

CLINICALLY PROVEN
to reduce the duration of the common cold®+

#1 PHARMACIST RECOMMENDED

18 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Sugar Free
Pomegranate

• + 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+

INGREDIENTS AND APPEARANCE

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-324
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
GLYCINE (UNII: TE7660XO1C)
ISOMALT (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (semi-translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	CHERRY	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-324-83	1 in 1 BOX	10/11/2018
1		18 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 46017-324-84	18 in 1 BAG; Type 0: Not a Combination Product	09/28/2018
3	NDC: 46017-324-44	1 in 1 BOX	10/12/2018
3		24 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		09/28/2018

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
GLYCINE (UNII: TE7660XO1C)
ISOMALT (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (semi-translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	HONEY (honey lemon)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-334-83	1 in 1 BOX	09/28/2028
1		18 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		09/28/2018

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-335
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
ISOMALT (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (semi-translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	POMEGRANATE	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-335-83	1 in 1 BOX	09/28/2028
1		18 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		09/28/2018

Labeler - Mylan Consumer Healthcare, Inc. (831410522)