COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU- zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, 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 Ingredients (2 gummies)	Purpose
Zincum Gluconicum 1X	Cold Remedy
Mentha piperita 1X	For temporary relief of cough
Sambucus nigra 2X	For temporary relief of flu symptoms
Eupatorium perfoliatum 2X	(cough, congestion and irritated respiratory tract)
Myrrha 2X	For temporary relief of Sore Throat
Glycyrrhiza G. L. (Licorice Root) 2X	For temporary relief of Irritated Throat

Uses

• to reduce the duration of the common cold
• reduces the severity of cold and flu symptoms: cough, sore throat, 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 for more than 7 days or are accompanied by fever, rash or persistent headache

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

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

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 gummies when you have cold or flu symptoms
• Adults:
  • Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth.
  • Take 2 gummies 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 12 gummies for adults and 8 gummies 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 gummies on an empty stomach to avoid possible minor stomach upset
• Store in a cool and dry place

Inactive ingredients

Citric acid, corn syrup, gelatin, glycine, maltodextrin, natural flavors and colors from fruits and vegetables, pectin and sugar (from beets)

Questions or Comments

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

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

PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label

NEW
for
Adults &
Kids 12
& up

Cold-EEZE®
ZINC GLUCONATE GLYCINE

gummies

SHORTENS YOUR COLD,
WORKS FASTER®+

Plus
Multi-Symptom
Relief
Cold & Flu

36
gummies
HOMEOPATHIC

Also Helps Relieve:

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

NATURAL FLAVOR
Mixed Fruit

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0234
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]
Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9)	Mentha Piperita	1 [hp_X]
eupatorium perfoliatum flowering top (UNII: 1W0775VX6E) (eupatorium perfoliatum flowering top - UNII:1W0775VX6E)	eupatorium perfoliatum flowering top	2 [hp_X]
sambucus nigra flower (UNII: 07V4DX094T) (sambucus nigra flower - UNII:07V4DX094T)	sambucus nigra flower	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	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Corn Syrup (UNII: 9G5L16BK6N)
Gelatin, Unspecified (UNII: 2G86QN327L)
Glycine (UNII: TE7660XO1C)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
Pectin (UNII: 89NA02M4RX)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	15mm
Flavor	BERRY (Mixed Berry)	Imprint Code	Smiley;Face
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0234-0	36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		10/01/2016

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0234)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	PACK(61941-0234) , ANALYSIS(61941-0234) , REPACK(61941-0234) , MANUFACTURE(61941-0234)