COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU- zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top

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

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Active ingredient:
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37), Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9), eupatorium perfoliatum flowering top (UNII: 1W0775VX6E) (eupatorium perfoliatum flowering top - UNII:1W0775VX6E), sambucus nigra flower (UNII: 07V4DX094T) (sambucus nigra flower - UNII:07V4DX094T), MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L), 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, congestion, post nasal drip and/or hoarseness - helps for temporary relief of Sore Throat
Authorization status:
unapproved homeopathic
Authorization number:
61941-0234-0

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

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

Gummies Plus Multi-Symptom Relief Cold and Flu

Drug Facts

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

Us es

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)

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:

NATURAL FLAVOR

Mixed Fruit

Cough

+

Conges tion

+

Sore Throat

+

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 41-0 234

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Zinc Gluco na te (UNII: U6 WSN5SQ1Z) (ZINC CATION - UNII:13S1S8 SF37)

Zinc Gluco nate

1 [hp_X]

Mentha Piperita (UNII: 79 M2M2UDA9 ) (Mentha Piperita - UNII:79 M2M2UDA9 )

Mentha Piperita

1 [hp_X]

eupa to rium perfo lia tum flo wering to p (UNII: 1W0 775VX6 E) (eupato rium perfo liatum

flo wering to p - UNII:1W0 775VX6 E)

eupato rium perfo liatum

flo wering to p

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]

MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)

MYRRH

2 [hp_X]

GLYCYRRHIZA GLABRA LEAF (UNII: GH32M79 7Y9 ) (GLYCYRRHIZA GLABRA LEAF -

UNII:GH32M79 7Y9 )

GLYCYRRHIZA GLABRA

LEAF

2 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

Co rn Syrup (UNII: 9 G5L16 BK6 N)

Gela tin, Unspecified (UNII: 2G8 6 QN327L)

Glycine (UNII: TE76 6 0 XO1C)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

Pectin (UNII: 8 9 NA0 2M4RX)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

PURPLE

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

BERRY (Mixed Berry)

Imprint Code

Smile y;Fa c e

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 19 41-0 234-

36 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 1/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED HOMEOPATHIC

10 /0 1/20 16

Labeler -

ProPhase Labs, Inc. (620557298)

ProPhase Labs, Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro Phase Labs, Inc.

6 20 55729 8

LABEL(6 19 41-0 234)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharmalo z Manufacturing,

Inc .

0 6 710 19 9 8

PACK(6 19 41-0 234) , ANALYSIS(6 19 41-0 234) , REPACK(6 19 41-0 234) ,

MANUFACTURE(6 19 41-0 234)

Revised: 10/2016

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