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 ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (per tablet)	Purpose
Zincum Gluconicum 1X	Cold Remedy
Sambucus nigra 1X; Eupatorium perfoliatum 1X	For temporary relief of flu symptoms (cough, nasal and chest congestion and irritated respiratory tract)
Mentha Piperita 2X	For temporary relief of cough
Myrrha 2X	For temporary relief of Sore Throat
Glycyrrhiza G. L. (Licorice Root) 3X	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

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 breast feeding, 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:
  • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole
  • Take 1 tablet at the onset of symptoms
  • Repeat every 2-4 hours as needed until all symptoms subside
  • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
  • 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.

Questions or Comments

Call 1-800-505-2653
(M-F: 9AM-5PM EST)

SPL UNCLASSIFIED SECTION

Manufactured for and
Distributed by:
ProPhase Labs, Inc.
P.O. Box 1349, Doylestown
PA 18901

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

NEW QuickMelts®

GREAT
TASTE

Cold-EEZE®

Zinc Gluconate Glycine

COLD REMEDY

Plus Natural
Multi-Symptom Relief

Cold & Flu

+ Shortens Your Cold, Works Faster™
+ Helps Relieve:
• Cough
• Chest Congestion
• Sore Throat

24 QuickMelts®
Homeopathic

Natural
Honey Lemon
Flavor

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: 61941-0226
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 (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Honey (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOLS (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)

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: 61941-0226-5	36 in 1 CASE
1	NDC: 61941-0226-4	4 in 1 BOX
1	NDC: 61941-0226-1	6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 61941-0226-6	48 in 1 CASE
2	NDC: 61941-0226-4	4 in 1 BOX
2	NDC: 61941-0226-1	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		12/01/2014

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0226) , ANALYSIS(61941-0226) , REPACK(61941-0226)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0226) , PACK(61941-0226) , REPACK(61941-0226)