Medique Cold Eeze
Zinc Gluconate
Unifirst First Aid Corporation
Human Otc Drug
NDC 47682-478Medique Cold Eeze also known as Zinc Gluconate is a human otc drug labeled by 'Unifirst First Aid Corporation'. National Drug Code (NDC) number for Medique Cold Eeze is 47682-478. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Medique Cold Eeze drug includes Zinc Gluconate - 2 [hp_X]/1 . The currest status of Medique Cold Eeze drug is Active.
Drug Information:
| Drug NDC: | 47682-478 |
| 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: | Medique 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: | Unifirst First Aid Corporation |
| 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 Apr, 2020 |
| 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: | Unifirst First Aid Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 47682-478-73 | 25 NOT APPLICABLE in 1 BOX (47682-478-73) / 1 LOZENGE in 1 NOT APPLICABLE | 07 Apr, 2020 | 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:
Medique cold eeze zinc gluconate corn syrup zinc gluconate zinc cation sucrose glycine p (semi-translucent)
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 do not use for the treatment of influenza or allergies. this product is intended only to reduce the duration of the common cold and its symptoms. ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline, or are on coumadin (warfarin) therapy. zinc treatment may inhibit the absorption of these medicines. when using this product do not take on an empty stomach (to avoid possible minor stomach upset). stop use and ask a doctor if symptoms persist beyond 7 days. if pregnant or breast-feeding, ask a healthcare professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use for the treatment of influenza or allergies. this product is intended only to reduce the duration of the common cold and its symptoms. ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline, or are on coumadin (warfarin) therapy. zinc treatment may inhibit the absorption of these medicines. when using this product do not take on an empty stomach (to avoid possible minor stomach upset). stop use and ask a doctor if symptoms persist beyond 7 days. if pregnant or breast-feeding, ask a healthcare professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not take on an empty stomach (to avoid possible minor stomach upset).
Dosage and Administration:
Directions take one lozenge at the onset of symptoms dissolve entire lozenge in mouth do not chew do not swallow whole do not eat or drink for 15 minutes after use repeat every 2-4 hours until symptoms subside adults and children 18 years and over: do not exceed 6 lozenges per day children 12 to 18 years: do not exceed 4 lozenges per day children under 12 years: ask a doctor before use
Stop Use:
Stop use and ask a doctor if symptoms persist beyond 7 days.
Package Label Principal Display Panel:
Medique cold-eeze label medique® the # 1 best selling zinc lozenge brand cold-eeeze® zinc gluconate homeopathic pull to open shortens your cold #1 pharmacist recommended 25 lozenges (actual size) natural cherry flavor mdq
Further Questions:
Questions or comments? 1-800-505-2653 (mon-fri 8am-5pm est)