COLD-EEZE NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra flower, eupatorium perfoliatum flowering top, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (per tablet)

Zincum Gluconicum 1X

Sambucus nigra 1X

Eupatorium perfoliatum 1X

Mentha Piperita 2X

Myrrha 2X

Glycyrrhiza G. L. (Licorice Root) 3X

Purpose

Cold Remedy

For temporary relief of flu symptoms (cough, nasal and chest congestion and irritated respiratory tract)

For temporary relief of cough

For temporary relief of Sore Throat

For temporary relief of Irritated Throat

Uses

Take one QuickMelt every 2-4 hours per Directions on other side.

• to reduce the duration of the common cold
• reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion, post nasal drip and/or hoarseness
• helps for temporary relief of Sore Throat

Warnings,

Ask a doctor before use if you

• are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines
• are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA), or an auto-immune condition

Stop use and ask your healthcare practitioner

if symptoms persist beyond 7 days.

Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® is a combination product formulated to help you to reduce the duration of the common cold and to help relieve Cold and Flu symptoms. It is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding,

ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

• Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® when you have cold or flu symptoms
• Adults:
  • o Dissolve entire tablet in mouth. Do not chew. Do not swallow whole
  • o Take 1 tablet at the onset of symptoms
  • o Repeat every 2-4 hours as needed until all symptoms subside
  • o Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
  • o Recommended daily dose is 6 tablets for adults and 4 tablets for ages 12-17 years
• For children under 12 years of age, consult a healthcare practitioner before use

Other information

• Do not take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® on an empty stomach to avoid possible minor stomach upset
• Store in a cool and dry place

Inactive ingredients

beta carotene, crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural honey crystals, natural honey lemon flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc

Cold-EEZE® QuickMelts®dissolve quickly in the mouth without water, releasing zinc ions in the mouth. Some scientific studies suggest that the released zinc ions inhibit the cold virus’ ability to replicate.*

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

• + Shortens Your Cold
• + Also Helps Relieve:
  • Cough+
  • Chest Congestion+
  • Sore Throat+
• + Gluten Free
• + Dissolves quickly in the mouth without water
• + Releases zinc ions in the mouth

Questions or Comments

Call 1-800-505-2653
(M-F: 8AM-5PM ET)
www.ColdEEZE.com

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

Mylan.com

+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.

CEZ:328:44:CT:R1

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

#1 Pharmacist Recommended

Cold-EEZE®
ZINC GLUCONATE GLYCINE

Plus Natural

Multi-Symptom Relief

Cold & Flu

ALSO HELPS RELIEVE:

• ✓ Cough+
• ✓ Chest Congestion+
• ✓ Sore Throat+

24
QuickMelts®
HOMEOPATHIC

NATURAL FLAVOR

Honey Lemon

INGREDIENTS AND APPEARANCE

COLD-EEZE  NATURAL MULTI-SYMPTOM RELIEF
zinc gluconate, sambucus nigra flower, eupatorium perfoliatum flowering top, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-328
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	1 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	1 [hp_X]
Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E)	Eupatorium Perfoliatum Flowering Top	1 [hp_X]
Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9)	Mentha Piperita	2 [hp_X]
Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L)	Myrrh	2 [hp_X]
Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9)	Glycyrrhiza Glabra Leaf	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Glycine (UNII: TE7660XO1C)
.Beta.-Carotene (UNII: 01YAE03M7J)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Honey (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OCTAGON (8 sided)	Size	15mm
Flavor	LEMON (honey lemon)	Imprint Code	ZM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-328-44	4 in 1 BOX	02/14/2019
1		6 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		02/14/2019

Labeler - Mylan Consumer Healthcare, Inc. (831410522)