COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge

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]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredient (per lozenge)	Purpose
Zincum Gluconicum 2X	Cold Remedy
Sambucus nigra 2X	For temporary relief of flu symptoms (coughing, nasal congestion and irritated respiratory tract)
Glycyrrhiza G. L. (Licorice Root) 3X	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, nasal 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 Natural Multi-Symptom Relief Cold & Flu Lozenge 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 Natural Multi-Symptom Relief Cold & Flu Lozenges when you have cold or flu symptoms
• Adults:
  • Dissolve entire lozenge in mouth. Do not chew. Do not swallow whole
  • Take 1 lozenge 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 lozenges for adults and 4 lozenges 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 Natural Multi-Symptom Relief Cold & Flu Lozenges on an empty stomach to avoid possible minor stomach upset
• Store in a cool and dry place after opening; best if used within 6 months after opening

Inactive ingredients

Corn syrup, glycine, menthol, natural colors from beet and berry extracts, natural flavors and sucrose. No artificial colors or preservatives.

Questions or Comments

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

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

PRINCIPAL DISPLAY PANEL - 12 Lozenge Package

+ SHORTENS YOUR COLD

Cold-EEZE®
Zinc Gluconate Glycine

Plus Natural
Multi-Symptom Relief

COLD & FLU

CLINICALLY PROVEN
INGREDIENT

+ Shortens your cold, works faster®
+ Also helps relieve:
• ✓ Cough
• ✓ Congestion
• ✓ Sore Throat

12
Cold Remedy
Lozenges

Homeopathic

Actual size

All Natural
Mixed Berry Flavor

INGREDIENTS AND APPEARANCE

COLD-EEZE   PLUS NATURAL MULTI-SYMPTOM RELIEF
zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	2 [hp_X]
Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9)	Glycyrrhiza Glabra Leaf	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	23mm
Flavor	BERRY (Mixed Berry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0114-4	12 in 1 PACKAGE; Type 0: Not a Combination Product

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

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0114) , ANALYSIS(61941-0114) , REPACK(61941-0114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0114) , PACK(61941-0114) , REPACK(61941-0114)