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NDC 71205-0349-18 Cold-EEZE 2 [hp_X]/1 Details

Cold-EEZE 2 [hp_X]/1

Cold-EEZE is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is ZINC GLUCONATE.

Product Information

NDC	71205-0349
Product ID	71205-349_c553117e-c5ed-4247-93c7-01841ac5d5ad
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cold-EEZE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Gluconate
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	[hp_X]/1
Substance Name	ZINC GLUCONATE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0349-18 (71205034918)

Pricing Information	N/A
NDC Package Code	71205-349-18
Billing NDC	71205034918
Package	1 BAG in 1 BOX (71205-349-18) / 18 LOZENGE in 1 BAG
Marketing Start Date	2019-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c553117e-c5ed-4247-93c7-01841ac5d5ad Details

Active ingredient (per lozenge)

Zincum Gluconicum 2x

Purpose

Cold Remedy

Uses

•: to reduce the duration of the common cold
•: reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

Warnings

Ask a doctor before use if you

•: are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines

Stop use and ask your healthcare practitioner

if symptoms persist beyond 7 days.

Cold-EEZE® lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding,

ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

Adults and children 12 years and over:

•: take Cold-EEZE® when you have cold symptoms
•: completely dissolve a Cold-EEZE® lozenge in mouth (do not chew)
•: repeat every 2 - 4 hours as needed until all symptoms subside
•: recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12 - 17

Children under 12 years of age should consult a healthcare practitioner prior to use

Other information

•: do not take Cold-EEZE® lozenges on an empty stomach to avoid possible minor stomach upset
•: do not eat or drink for 15 minutes after use
•: store in a cool, dry place after opening; best if used within 6 months after opening
•: gluten free

Inactive ingredients

Corn syrup, glycine, natural flavors and sucrose.

No artificial colors or preservatives.

Clinical Studies have shown: The unique Cold-EEZE® formula reduces the duration of the common cold by almost half.

The double blind placebo controlled studies were conducted at the Cleveland Clinic and Dartmouth College and published in peer reviewed journals.

Cold-EEZE® is safe to take with most other medications and is gluten free. (see warnings)

Does Not Cause Drowsiness

Does Not Cause Light Headedness

Does Not Affect Blood Pressure

For cold-fighting tips and more about the Cold-EEZE® science, go to www.ColdEEZE.com

Questions or Comments:

Call 1-800-505-2653

(M-F: 8AM-5PM ET)

Mylan.com

Manufactured for:

Mylan Consumer Healthcare, Inc.

Morgantown, WV 26505 U.S.A.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

+THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

This product has no expiration date.

Principal Display Panel – Orange

NDC 71205-349-18

+SHORTENS YOUR COLD

Cold-EEZE®

Zinc Gluconate Glycine

•: Clinically proven to reduce the duration of the common cold®
•: #1 Pharmacist Recommended
•: Shortens your cold, works faster®

18 Cold Remedy

Lozenges

Homeopathic

All Natural

Tropical Orange Flavor

•: Take Cold-EEZE® when you have a cold
•: Continue until symptoms are gone
•: Our clinically proven formula releases zinc ions in the mouth that shorten the duration of the common cold

INGREDIENTS AND APPEARANCE

COLD-EEZE

zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-349(NDC:46017-325)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (semi-translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	ORANGE (tropical orange)	Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-349-18	1 in 1 BOX	11/01/2019
1		18 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		05/07/2018

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-349) , RELABEL(71205-349)

Revised: 11/2019

Document Id: c553117e-c5ed-4247-93c7-01841ac5d5ad

Set id: c553117e-c5ed-4247-93c7-01841ac5d5ad

Version: 1

Effective Time: 20191101