COLD-EEZE PLUS IMMUNE SUPPORT- zinc gluconate, rosa canina leaf, and echinacea purpurea 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., Blispak, 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
Rosa Canina L. (Rose Hip) 1X	Promotes Immune support
Echinacea Purpurea Extract 2X	Promotes Immune support

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.
• supports immune system health.

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 a skin condition called pemphigus vulgaris 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 Immune Support QuickMelts® is a combination product formulated to help you to reduce the duration of the common cold and its symptoms and promote immune system health. 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 Immune Support QuickMelts® when you have cold 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.
• For individuals under the age of 18, consult a healthcare practitioner before use.

Other information

• Do not take on an empty stomach to avoid possible minor stomach upset.
• Echinacea might cause a slight tingling sensation on the tongue.
• Store in a cool and dry place.

Other ingredients

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 24 Tablet Package

NEW QuickMelts®

GREAT
TASTE

Cold-EEZE®

Zinc Gluconate Glycine

COLD REMEDY

Plus Natural
Immune Support

• ✔ Shortens Your Cold, Works Faster
• ✔ Promotes Immune Health,
  Antioxidant Support
  • Rose Hips: Rich in Natural Vitamin C
  • Echinacea

24 QuickMelts®
Homeopathic

Natural
Orange Flavor

INGREDIENTS AND APPEARANCE

COLD-EEZE   PLUS IMMUNE SUPPORT
zinc gluconate, rosa canina leaf, and echinacea purpurea tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0223
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]
ROSA CANINA LEAF (UNII: J3N2Z889QP) (ROSA CANINA LEAF - UNII:J3N2Z889QP)	ROSA CANINA LEAF	1 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	2 [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)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MENTHOL (UNII: L7T10EIP3A)
ORANGE (UNII: 5EVU04N5QU)
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	WHITE	Score	no score
Shape	OCTAGON (8 SIDED)	Size	15mm
Flavor	ORANGE (NATURAL)	Imprint Code	ZC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0223-4	4 in 1 PACKAGE
1	NDC: 61941-0223-1	6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		09/01/2013

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0223) , ANALYSIS(61941-0223) , REPACK(61941-0223)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	PACK(61941-0223) , REPACK(61941-0223)

Establishment
Name	Address	ID/FEI	Business Operations
Blispak, Inc.		194902235	MANUFACTURE(61941-0223) , ANALYSIS(61941-0223) , PACK(61941-0223)