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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37), Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T), Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9)
Available from:
ProPhase Labs, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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
Authorization status:
unapproved homeopathic
Authorization number:
61941-0114-4

COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra

flower, and glycyrrhiza glabra leaf lozenge

ProPhase Labs, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Cold-EEZE

Plus Natural Multi-Symptom Relief

Drug Facts

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

Us es

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)

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

+

+

12

Cold Remedy

Lozenges

Homeopathic

Actual size

All Natural

Mixed Berry Flavor

®

Shortens your cold, works faster

®

Also helps relieve:

Cough

Conges tion

Sore Throat

COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF

zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 41-0 114

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Zinc Gluco na te (UNII: U6 WSN5SQ1Z) (Zinc Catio n - UNII:13S1S8 SF37)

Zinc Gluco nate

2 [hp_X]

Sa mbucus Nig ra Flo wer (UNII: 0 7V4DX0 9 4T) (Sambucus Nigra Flo wer - UNII:0 7V4DX0 9 4T)

Sambucus Nigra Flo wer

2 [hp_X]

Glycyrrhiza Gla bra Lea f (UNII: GH32M79 7Y9 ) (Glycyrrhiza Glabra Leaf - UNII:GH32M79 7Y9 )

Glycyrrhiza Glabra Leaf

3 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

Co rn Syrup (UNII: 9 G5L16 BK6 N)

Glycine (UNII: TE76 6 0 XO1C)

Mentho l, Unspecified Fo rm (UNII: L7T10 EIP3A)

Sucro se (UNII: C151H8 M554)

ProPhase Labs, Inc.

Product Characteristics

Color

PURPLE

S core

no sco re

S hap e

OVAL

S iz e

23mm

Flavor

BERRY (Mixed Berry)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 41-0 114-4

12 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED HOMEOPATHIC

0 1/0 1/20 16

Labeler -

ProPhase Labs, Inc. (620557298)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro Phase Labs, Inc.

6 20 55729 8

LABEL(6 19 41-0 114) , ANALYSIS(6 19 41-0 114) , REPACK(6 19 41-0 114)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharmalo z Manufacturing, Inc.

0 6 710 19 9 8

MANUFACTURE(6 19 41-0 114) , PACK(6 19 41-0 114) , REPACK(6 19 41-0 114)

Revised: 1/2016

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