COLD-EEZE COLD REMEDY- zinc gluconate lozenge

Cold-EEZE Cold Remedy by

Drug Labeling and Warnings

Cold-EEZE Cold Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Vespyr Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Active ingredient (per lozenge )
Zinc Gluconate 2X HPUS † (2.3%) (13.3 mg zinc)

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

Purposes

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)
• it may cause a laxative effect

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

acesulfame-K, glycine, isomalt, natural flavors

Questions of comments?

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

PRINCIPAL DISPLAY PANEL

Cold-EEZE ®

COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD ®

SUGAR FREE

NATURAL WILD CHERRY FLAVOR

25 Zinc Lozenges

CLINICALLY TESTED to Shorten Colds by 42%*

Pharmacist Recommended

©2022 Vespyr Brands ®, Inc.

All rights reserved

Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands®, Inc.

East Windsor, NJ 08520

*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.

This product has not been evaluated by the FDA

INGREDIENTS AND APPEARANCE

COLD-EEZE COLD REMEDY 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71179-324
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	13.3 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)
ISOMALT (UNII: S870P55O2W)
ACESULFAME (UNII: MA3UYZ6K1H)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	OVAL	Size	23mm
Flavor	CHERRY	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71179-324-02	25 in 1 BOX	06/29/2022
1		1 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/29/2022

Labeler - Vespyr Brands Inc (118094893)