Label: COLD-EEZE- zinc gluconate lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-4156-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 46017-320
- 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 February 27, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per lozenge)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you
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- are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines
Stop use and ask your healthcare practitioner
if symptoms persist beyond 7 days.Cold-EEZE® lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.
- If pregnant or breastfeeding,
- Keep out of reach of children.
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Directions
Adults and children 12 years and over:
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- take Cold-EEZE® when you have cold symptoms
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- completely dissolve a Cold-EEZE® lozenge in mouth (do not chew)
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- repeat every 2 - 4 hours as needed until all symptoms subside
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- recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12 - 17
Children under 12 years of age should consult a healthcare practitioner prior to use
- Other information
- Inactive ingredients
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Clinical Studies have shown: The unique Cold-EEZE® formula reduces the duration of the common cold by almost half.
The double blind placebo controlled studies were conducted at the Cleveland Clinic and Dartmouth College and published in peer reviewed journals.
Cold-EEZE® is safe to take with most other medications and is gluten free. (see warnings)
Does Not Cause Drowsiness
Does Not Cause Light Headedness
Does Not Affect Blood Pressure
For cold-fighting tips and more about the Cold-EEZE® science, go to www.ColdEEZE.com
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Questions or Comments:
Call 1-800-505-2653
(M-F: 8AM-5PM ET)Mylan.com
Manufactured for:
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 U.S.A.+THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
This product has no expiration date.
- HOW SUPPLIED
- Zinc Gluconate
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INGREDIENTS AND APPEARANCE
COLD-EEZE
zinc gluconate lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4156(NDC:46017-320) 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] 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 CHERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-4156-0 1 in 1 BOX 02/22/2019 1 18 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 05/07/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4156)
