COLD-EEZE NATURAL ALLERGY RELIEF- onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed release

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 (per caplet)

Allium Cepa L 2X
Eupatorium perfoliatum 1X
Polygonum fagopyrum L. 2X
Pothos Foetidus 2X
Sambucus nigra 1X
Tussilago petasites L.1X
Urtuca dioica 1X
Zincum Gluconicum 2X

Purpose

For temporary relief of symptoms associated with allergies

Uses

For temporary relief of symptoms associated with allergies: Breathing difficulties, headache, congestion, itchy eyes, runny nose, stuffy nose and bronchial spasms

Warnings

Ask a doctor before use if you

• Are on anticoagulant therapy, barbiturates, or are under medical supervision for diabetes and are taking diabetes medication, as sambucus nigra (Elder Flower) can decrease blood sugar levels

Stop use and ask your healthcare practitioner if you have noticed any allergic reaction or rashes or if symptoms persist beyond 5 days.

Cold-EEZE® Natural Allergy Relief is formulated to help you with temporary relief of symptoms associated with indoor/outdoor and seasonal allergies

If pregnant or breast feeding, ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

• Take Cold-EEZE® Natural Allergy Symptom Relief when you have allergy symptoms
• For ages 12 years and older:
  • Take 1 caplet with water
  • Repeat every 8-12 hours as needed until all symptoms subside
  • Do Not Take more than 3 caplets per day
• Recommended daily dose is 2 caplets per day
• For individuals under the age of 12, consult a healthcare practitioner before use

Other information

• Do not crush or divide the Cold-EEZE® Natural Allergy Symptom Relief caplets
• Store in a dark, cool and dry place

Inactive ingredients

Carbopol, dibasic calcium phosphate, magnesium stearate, methocel, microcrystalline cellulose, silicon dioxide, stearic acid.

Questions or Comments

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Box

NEW

From the makers of
Cold-EEZE®

NATURAL
ALLERGY
RELIEF™

Up to 12 Hours Extended-Release

For Relief of:

• ☑ Congestion
• ☑ Itchy Eyes
• ☑ Runny Nose
  & Stuffy Nose

Non
Drowsy

20
Coated
Caplets

Homeopathic

Actual size

For Indoor
& Outdoor
Allergies

INGREDIENTS AND APPEARANCE

COLD-EEZE   NATURAL ALLERGY RELIEF
onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0229
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H)	Onion	2 [hp_X]
Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E)	Eupatorium Perfoliatum Flowering Top	1 [hp_X]
Buckwheat (UNII: N0Y68724R3) (Buckwheat - UNII:N0Y68724R3)	Buckwheat	2 [hp_X]
Symplocarpus Foetidus Root (UNII: R88254608W) (Symplocarpus Foetidus Root - UNII:R88254608W)	Symplocarpus Foetidus Root	2 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	1 [hp_X]
Tussilago Farfara Leaf (UNII: G2GH7V846Z) (Tussilago Farfara Leaf - UNII:G2GH7V846Z)	Tussilago Farfara Leaf	1 [hp_X]
Urtica Dioica (UNII: 710FLW4U46) (Urtica Dioica - UNII:710FLW4U46)	Urtica Dioica	1 [hp_X]
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Methylcellulose (25 MPA.S) (UNII: BI55GG2WLI)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	GRAY	Score	no score
Shape	OVAL	Size	2mm
Flavor		Imprint Code	ZA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0229-4	2 in 1 BOX
1	NDC: 61941-0229-1	10 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		01/01/2016

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0229) , ANALYSIS(61941-0229) , REPACK(61941-0229)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0229) , PACK(61941-0229) , REPACK(61941-0229)