Label: COLD-EEZE - zinc gluconate lozenge
- NDC Code(s): 61941-0111-1, 61941-0111-2, 61941-0111-3, 61941-0111-8
- Packager: ProPhase Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
Updated April 4, 2011
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- SPL UNCLASSIFIED SECTION
- Active ingredient (per lozenge)
Zincum Gluconicum 2x (13.3mg)Close
Homeopathic Cold RemedyClose
- to reduce the duration of the common cold
- reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness
Ask a doctor before use if you
- are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines
COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.
- adults and children 12 years and over
- for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
- repeat every 2 - 4 hours as needed until all symptoms subside
- completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
- recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
- children under 12 years of age should consult a health professional prior to use
- Other information
- avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
- avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
- STORAGE AND HANDLING
- store in a cool dry place after opening
- SPL UNCLASSIFIED SECTION
- Inactive ingredients
corn syrup, honey, glycine, lemon oil, natural green tea flavor and sucrose. No artificial colors or preservatives.Close
- QUESTIONS? COMMENTS?
9am - 5pm Eastern
- PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton
Shorten your cold!
Get better faster!
Clinically proven to
reduce the duration
of the common cold
Natural Green Tea
with Honey Flavor
with other natural flavors
- INGREDIENTS AND APPEARANCE
zinc gluconate lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0111 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS) Zinc Gluconate 2 [hp_X] Inactive Ingredients Ingredient Name Strength Corn Syrup (UNII: 9G5L16BK6N) Glycine (UNII: TE7660XO1C) Sucrose (UNII: C151H8M554) Product Characteristics Color WHITE (Semi-Translucent) Score no score Shape OVAL Size 23mm Flavor FIG (Green Tea) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0111-1 24 in 1 CASE 1 NDC:61941-0111-8 18 in 1 PACKAGE 2 NDC:61941-0111-2 48 in 1 CASE 2 NDC:61941-0111-8 18 in 1 PACKAGE 3 NDC:61941-0111-3 144 in 1 CASE 3 NDC:61941-0111-8 18 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 02/01/2003 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL, ANALYSIS Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE, ANALYSIS, PACK, REPACK