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

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Homeopathic medication manufactured, distributed, or labeled by Mylan Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (per lozenge)

Zinc Gluconate 1X HPUS† (2.22%) (13.3 mg zinc)
Sambucus Nigra 1X HPUS† (1.11%)
Avena Sativa L. 2X HPUS† (0.02%)
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.

Purpose

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

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.

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)

SPL UNCLASSIFIED SECTION

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.

This product has no expiration date

Principal Display Panel – Citrus with Elderberry

NDC: 46017-323-96

Cold-EEZE®
HOMEOPATHIC

SHORTENS YOUR COLD

Plus DEFENSE

• ✓ Promotes Immune Health*
• ✓ Helps with Fatigue*

12 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Citrus with Elderberry

• + Shortens your cold
• + Promotes Immune Health*
• + Helps with Fatigue*
• + Releases zinc ions in the mouth®
• + #1 pharmacist recommended zinc lozenge brand

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

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

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

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

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

Labeler - Mylan Consumer Healthcare, Inc. (831410522)