COLD-EEZE COLD REMEDY ULTRAMELT CHEWS- zinc gluconate tablet, chewable

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 tablet )
Zinc Gluconate 1X HPUS † (2.22%) (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)

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 chewable tablet at the onset of symptoms chew slowly and dissolve completely in mouth before swallowing
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 chewable tablets per day
• Children 12 to under 18 years: do not exceed 4 chewable tablets 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 potassium, erythritol, FD&C red no. 40 aluminum lake, FD&C yellow No. 5 (tartrazine) aluminum lake, glycine, hydroxypropyl cellulose, isomalt, magnesium stearate, natural flavors, sucarlose, xylitol

Questions?

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

PRINCIPAL DISPLAY PANEL

Cold-EEZE ®

COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD ®

UltraMELT ® Chews

GREAT Tasting

QUICK DISSOLVING Tablets

NATURAL ORANGE FLAVOR

24 Chewable Tablets

©2022 Vespyr Brands ®, Inc.

Cold-EEZE ® and ULTRAMELT ® are registered trademarks of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands ®, Inc.

East Windsor, NJ 08520 USA

This product has not been evaluated by the FDA

Made in Denmark

www.coldeeze.com

INGREDIENTS AND APPEARANCE

COLD-EEZE COLD REMEDY  ULTRAMELT CHEWS
zinc gluconate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71179-350
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
XYLITOL (UNII: VCQ006KQ1E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOMALT (UNII: S870P55O2W)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
ERYTHRITOL (UNII: RA96B954X6)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)

Product Characteristics
Color	white (2nd side orange-pink)	Score	score with uneven pieces
Shape	ROUND	Size	11mm
Flavor	ORANGE	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71179-350-24	2 in 1 BOX	07/01/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2021

Labeler - Vespyr Brands Inc (118094893)