COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra 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 2X HPUS† (2.22%) (13.3 mg zinc)
Sambucus Nigra 2X HPUS† (1.0%)
Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)

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

Purpose

Cold Remedy
relieves cough, nasal congestion and irritated respiratory tract*
relieves irritated throat*

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
• temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with colds and flu*

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu 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 doctor if

symptoms persist beyond 7 days

If pregnant or breastfeeding,

ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

• take one lozenge 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

‡Based on the Cold-EEZE brand unit sales of cold shortening, homeopathic zinc lozenges.

©2019 Mylan Inc.

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

This product has no expiration date

Principal Display Panel – Mixed Berry

NDC: 46017-322-96

Cold-EEZE
HOMEOPATHIC

SHORTENS YOUR COLD

Plus Natural
Multi-Symtpom Relief*
Cold & Flu

12 LOZENGES
HOMEOPATHIC

RESEALABLE BAG INSIDE

NATURAL FLAVOR
Mixed Berry

• + Shortens your cold
• + Also helps relieve:
  • ✓ Cough*
  • ✓ Congestion*
  • ✓ Sore Throat*
• + Gluten Free
• + Releases zinc ions in the mouth®
• + #1 pharmacist recommended zinc lozenge brand

INGREDIENTS AND APPEARANCE

COLD-EEZE  PLUS NATURAL MULTI-SYMPTOM RELIEF
zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	2 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T)	Sambucus Nigra Flower	2 [hp_X]
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9) (GLYCYRRHIZA GLABRA LEAF - UNII:GH32M797Y9)	GLYCYRRHIZA GLABRA LEAF	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	23mm
Flavor	BERRY (mixed berry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-322-96	1 in 1 BOX	09/12/2018
1		12 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		09/12/2018

Labeler - Mylan Consumer Healthcare, Inc. (831410522)