COLD-EEZE- zinc gluconate lozenge

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Homeopathic medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per lozenge)

Zincum Gluconicum 2x 

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.

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

Inactive ingredients

Corn syrup, glycine, natural flavors and sucrose.

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)

Mylan.com

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

+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.

HOW SUPPLIED

Product: 50090-4156

NDC: 50090-4156-0 18 LOZENGE in a BAG / 1 in a BOX

Zinc Gluconate

INGREDIENTS AND APPEARANCE

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-4156(NDC:46017-320)
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

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: 50090-4156-0	1 in 1 BOX	02/22/2019
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		05/07/2018

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-4156)