Cold-eeze
Zinc Gluconate
Proficient Rx Lp
Human Otc Drug
NDC 71205-349Cold-eeze also known as Zinc Gluconate is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Cold-eeze is 71205-349. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Cold-eeze drug includes Zinc Gluconate - 2 [hp_X]/1 . The currest status of Cold-eeze drug is Active.
Drug Information:
| Drug NDC: | 71205-349 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cold-eeze |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Zinc Gluconate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lozenge |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ZINC GLUCONATE - 2 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 07 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | U6WSN5SQ1Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71205-349-18 | 1 BAG in 1 BOX (71205-349-18) / 18 LOZENGE in 1 BAG | 01 Nov, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose cold remedy
Product Elements:
Cold-eeze zinc gluconate zinc gluconate zinc cation corn syrup glycine sucrose semi-translucent p tropical orange
Indications and Usage:
Uses ⢠to reduce the duration of the common cold ⢠reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
Warnings:
Warnings ask a doctor before use if you ⢠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.
Dosage and Administration:
Directions adults and children 12 years and over: ⢠take cold-eeze ® when you have cold symptoms ⢠completely dissolve a cold-eeze ® lozenge in mouth (do not chew) ⢠repeat every 2 - 4 hours as needed until all symptoms subside ⢠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
Package Label Principal Display Panel:
Principal display panel â orange ndc 71205-349-18 + shortens your cold cold-eeze ® zinc gluconate glycine ⢠clinically proven to reduce the duration of the common cold ® ⢠#1 pharmacist recommended ⢠shortens your cold, works faster® 18 cold remedy lozenges homeopathic all natural tropical orange flavor ⢠take cold-eeze ® when you have a cold ⢠continue until symptoms are gone ⢠our clinically proven formula releases zinc ions in the mouth that shorten the duration of the common cold 71205-349-18
Further Questions:
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. relabeled by: proficient rx lp thousand oaks, ca 91320 + 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.