COLD-EEZE PLUS DEFENSE- zinc gluconate, sambucus nigra flower, rosa canina leaf, echinacea purpurea, and avena sativa leaf lozenge
Mylan Consumer Healthcare, 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.

----------

Drug Facts

Active Ingredients (per lozenge)

Zinc Gluconate 1X HPUS† (2.22%) (13.3 mg zinc)
Sambucus Nigra 1X HPUS† (1.11%)
Avena Sativa L. 2X HPUS† (0.14%)
Rosa Canina (Rose Hips) 2X HPUS† (0.09%)
Echinacea Purpurea 3X HPUS† (0.04%)

†The letters ‘HPUS’ indicates that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purposes

Cold Remedy
Promotes immune support*
Helps with general debility and fatigue*
Promotes immune support*
Promotes immune support*

Uses

•: reduces the duration of the common cold
•: reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
•: supports immune system health*
•: helps with a general debility and fatigue*

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.

Ask a doctor before use if you have

•: diabetes
•: multiple sclerosis (MS)
•: rheumatoid arthritis (RA) or other auto-immune condition

Ask a doctor or pharmacist before use if you are

taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When using this product

do not take on an empty stomach (to avoid possible minor stomach upset).

Stop use and ask your healthcare practitioner if

symptoms persist beyond 7 days.

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

•: take one at the onset of symptoms
•: do not swallow whole
•: dissolve entire lozenge in mouth
•: do not eat or drink for 15 minutes after use
•: do not chew
•: repeat every 2-4 hours until symptoms subside

Adults 18 years and over	do not exceed 6 lozenges per day
Children 12 to under 18 years	do not exceed 4 lozenges per day
Children under 12 years	ask a doctor before use

Other information

•: store in a cool, dry place after opening
•: best if used within 6 months after opening

Inactive ingredients

Corn syrup, glycine, natural colors, natural flavors and sucrose.

Questions or comments?

Call 1-800-505-2653 (Monday-Friday: 8am-5pm EST)

This product has not been evaluated by the FDA.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

No artificial colors or preservatives

Manufactured for:
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 U.S.A.

Principal Display Panel – Citrus with Elderberry

NDC 46017-323-25

The #1 Best Selling Zinc Lozenge Brand‡

Cold-EEZE®
COLD REMEDY

HOMEOPATHIC

SHORTENS YOUR COLD®

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

25
Lozenges

NATURAL FLAVOR
CITRUS WITH ELDERBERRY

✓: Shortens your cold
✓: Promotes Immune Health*
✓: Helps with Fatigue*
✓: No artificial colors or preservatives

Learn more about Cold-EEZE®
at www.coldeeze.com

✓: Releases zinc ions in the mouth® and shortens the duration of the common cold
✓: Pharmacist recommended zinc lozenge brand

UC-32325-25-02

Manufactured for:
Mylan Consumer
Healthcare, Inc.
Morgantown,
WV 26505 U.S.A.

Mylan.com

Cold-EEZE Plus Defense Carton Label Citrus with Elderberry

Principal Display Panel – Manuka Honey Lemon

NDC 46017-342-25

The #1 Best Selling Zinc Lozenge Brand‡

Cold-EEZE®
COLD REMEDY

HOMEOPATHIC

SHORTENS YOUR COLD®

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

25
Lozenges

NATURAL FLAVOR
MANUKA HONEY LEMON

✓: Shortens your cold
✓: Promotes Immune Health*
✓: Helps with Fatigue*
✓: No artificial colors or preservatives

Learn more about Cold-EEZE®
at www.coldeeze.com

✓: Releases zinc ions in the mouth® and shortens the duration of the common cold
✓: Pharmacist recommended zinc lozenge brand

UC-34225-25-03

Manufactured for:
Mylan Consumer
Healthcare, Inc.
Morgantown,
WV 26505 U.S.A.

Mylan.com

Cold-EEZE Plus Defense Carton Label Manuka Honey Lemon

COLD-EEZE PLUS DEFENSE
zinc gluconate, sambucus nigra flower, rosa canina leaf, echinacea purpurea, and avena sativa leaf lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46017-323
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	1 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	1 [hp_X]
ROSA CANINA LEAF (UNII: J3N2Z889QP) (ROSA CANINA LEAF - UNII:J3N2Z889QP)	ROSA CANINA LEAF	2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	3 [hp_X]
AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R)	AVENA SATIVA LEAF	2 [hp_X]

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

Product Characteristics
Color	BROWN (amber)	Score	no score
Shape	OVAL	Size	23mm
Flavor	CITRUS (citrus with elderberry)	Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46017-323-25	1 in 1 BOX	06/12/2020	10/31/2022
1		25 in 1 BAG; Type 0: Not a Combination Product
2	NDC:46017-323-96	1 in 1 BOX	08/28/2018	10/31/2022
2		12 in 1 BAG; Type 0: Not a Combination Product
3	NDC:46017-323-95	1 in 1 BOX	10/10/2018	10/31/2022
3		16 in 1 BAG; Type 0: Not a Combination Product
4	NDC:46017-323-90	2 in 1 BAG; Type 0: Not a Combination Product	11/16/2018	10/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		08/28/2018	10/31/2022

COLD-EEZE PLUS DEFENSE
zinc gluconate, sambucus nigra flower, rosa canina leaf, echinacea purpurea, and avena sativa leaf lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46017-342
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	1 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	1 [hp_X]
ROSA CANINA LEAF (UNII: J3N2Z889QP) (ROSA CANINA LEAF - UNII:J3N2Z889QP)	ROSA CANINA LEAF	2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	3 [hp_X]
AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R)	AVENA SATIVA LEAF	2 [hp_X]

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

Product Characteristics
Color	BROWN	Score	no score
Shape	OVAL	Size	23mm
Flavor	LEMON (manuka honey lemon)	Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46017-342-25	1 in 1 BOX	06/12/2020	10/31/2022
1		25 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		06/12/2020	10/31/2022

Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 10/2020

Document Id: 22e6e065-803a-4c8f-ab34-b59149e65bed

Set id: 035587ba-b51f-4328-83a8-0ae2ea2c5111

Version: 9

Effective Time: 20201029

Mylan Consumer Healthcare, Inc.