COLD-EEZE HOMEOPATHIC- zinc gluconate, rosa canina, echinacea purpurea chewable gel

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 ingredients

(per chewable gel)

Zinc Gluconate 1X HPUS† (8.8%) (13.2 mg zinc)

Rosa Canina (Rose Hips)
2X HPUS† (1.0%)

Echinacea Purpurea 1X HPUS† (0.02%)

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

Purposes

Cold remedy

Promotes immune support*

Promotes immune support*

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
• supports immune system health*

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

Stop use and ask your doctor if

symptoms persist for more than 7 days

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

 

Directions

• take one chewable gel at onset of symptoms
• chew slowly and dissolve completely in mouth before swallowing
• do not swallow whole
• do not eat or drink for 15 minutes after use
• repeat every 2-4 hours until symptoms subside

• Adults 18 years and over:

  do not exceed 6 chewable gels per day

• Children 12 to under 18 years:

  do not exceed 4 chewable gels per day

• Children under 12 years:

  ask a doctor before use

Other information

• each chewable gel contains: sodium 10mg
• store at room temperature in a cool, dry place
• do not expose to excessive heat for long periods of time

Inactive Ingredients

citric acid, corn syrup, flavors, glycine, malic acid, pectin, sambucus nigra (european elder),
sucrose, sugar, tricalcium phosphate, trisodium citrate dihydrate, water

Questions or comments?

Call 1-800-505-2653 (Monday-Friday: 8AM-5PM EST)

COLDEEZE® is a registered trademark
of Mylan Consumer Healthcare Inc.

Principal Display Panel – 25 Chewable Gels

Cold-EEZE®

HOMEOPATHIC

SHORTENS YOUR COLD
Plus DEFENSE

• ✓ Promotes
  Immune Health*

25 CHEWABLE GELS

Citrus
with
Elderberry
NATURAL FLAVOR

DO NOT USE IF SEAL UNDER CAP IS
BROKEN OR MISSING.

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

DISTRIBUTED BY:
MYLAN CONSUMER HEALTHCARE, INC.
MORGANTOWN, WV 26505 U.S.A.

Mylan.com

This product has not been
evaluated by the FDA.

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

NDC: 46017-341-25      LB-34125-25-03

At the first sign of a cold, take one
chewable gel.

See Directions on other side of label.

INGREDIENTS AND APPEARANCE

COLD-EEZE  HOMEOPATHIC
zinc gluconate, rosa canina, echinacea purpurea chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-341
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]
ROSA CANINA FRUIT (UNII: 3TNW8D08V3) (ROSA CANINA FRUIT - UNII:3TNW8D08V3)	ROSA CANINA FRUIT	2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CORN SYRUP (UNII: 9G5L16BK6N)
GLYCINE (UNII: TE7660XO1C)
MALIC ACID (UNII: 817L1N4CKP)
PECTIN (UNII: 89NA02M4RX)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
SUCROSE (UNII: C151H8M554)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	CITRUS (Citrus with Elderberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-341-25	25 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		07/01/2019

Labeler - Mylan Consumer Healthcare, Inc. (831410522)