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

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Drug Facts

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)

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
Cold-EEZE Plus Natural Carton Label
COLD-EEZE  PLUS NATURAL MULTI-SYMPTOM RELIEF
zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower2 [hp_X]
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9) (GLYCYRRHIZA GLABRA LEAF - UNII:GH32M797Y9) GLYCYRRHIZA GLABRA LEAF3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Corn Syrup (UNII: 9G5L16BK6N)  
Glycine (UNII: TE7660XO1C)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sucrose (UNII: C151H8M554)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize23mm
FlavorBERRY (mixed berry) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-322-961 in 1 BOX09/12/201810/31/2022
112 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic09/12/201810/31/2022
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 12/2017
Document Id: 5076cb25-6b6a-4354-8cb8-c33f6686261d
Set id: f65c143a-47ec-4939-813b-2d31d3294fd3
Version: 3
Effective Time: 20171218
 
Mylan Consumer Healthcare, Inc.