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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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