Label: COLD-EEZE- zinc gluconate lozenge
-
Contains inactivated NDC Code(s)
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
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.
Drug Label Information
Updated April 4, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per lozenge)
- Purpose
- Uses
-
Warnings
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
-
Directions
- 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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Inactive ingredients
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton
-
INGREDIENTS AND APPEARANCE
COLD-EEZE
zinc gluconate lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0111 Route of Administration ORAL 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