Topcare Health Cold Remedy Cherry Flavor
Zincum Gluconicum
Topco Associates Llc
Human Otc Drug
NDC 36800-805Topcare Health Cold Remedy Cherry Flavor also known as Zincum Gluconicum is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Topcare Health Cold Remedy Cherry Flavor is 36800-805. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Topcare Health Cold Remedy Cherry Flavor drug includes Zinc Gluconate - 1 [hp_X]/1 . The currest status of Topcare Health Cold Remedy Cherry Flavor drug is Active.
Drug Information:
| Drug NDC: | 36800-805 |
| 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: | Topcare Health Cold Remedy Cherry Flavor |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Topcare Health Cold Remedy |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Cherry Flavor |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Zincum Gluconicum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Topco Associates Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 - 1 [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: | 17 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | TOPCO ASSOCIATES LLC
|
| 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 |
|---|
| 36800-805-25 | 25 TABLET in 1 BOTTLE, PLASTIC (36800-805-25) | 17 Apr, 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:
Topcare health cold remedy cherry flavor zincum gluconicum zinc gluconate zinc cation ascorbic acid crospovidone (120 .mu.m) magnesium stearate sorbitol starch, corn sucralose biconcave rp118
Indications and Usage:
Uses ? may help reduce duration and severity of cold symptoms: ? sore throat ? stuffy nose ? sneezing ? coughing this product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies. warnings ask a doctor before use if you have ? a sensitivity to zinc or are allergic zinc ? are taking minocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines. stop use and ask a doctor if symptoms persist beyond 7 days. if pregnant or breast feeding as ask health professional before use. keep out of reach of children in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
Warnings:
Warnings ask a doctor before use if you have ? a sensitivity to zinc or are allergic zinc ? are taking minocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines. stop use and ask a doctor if symptoms persist beyond 7 days. if pregnant or breast feeding as ask health professional before use. keep out of reach of children in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
Dosage and Administration:
Directions ? for best results, use at the first sign of a cold and continue to use as directed ? adults and children 12 years of age and older: ? chew one tablet completely at the onset of symptoms. do not swallow tablets whole. ? repeat every 3 hours until symptoms are gone ? to avoid minor stomach upset, do not take on an empty stomach. ? do not eat or drink for 15 minutes after use. do not eat or drink citrus fruits or juices for 30 minutes before or after use. otherwise, drink plenty of fluids. ? recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17 ? children under 12 years of age: consult a doctor before use.
Stop Use:
Stop use and ask a doctor if symptoms persist beyond 7 days. if pregnant or breast feeding as ask health professional before use. keep out of reach of children in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
Package Label Principal Display Panel:
Principal display panel topcare health ndc 36800-805-25 *compare to zicam ® cold remedy rapidmelts ® active ingredient* homeopathic cold remedy zincum gluconicum take at the first sign of a cold may help reduce the duration of cold symptoms* sugar-free cherry flavor naturally & artificially flavored 25 chewable tablets ? quality guaranteed do not use if printed inner seal under cap is broken or missing. claim is based only on theories of homeopathy from 1700s not accepted by most modern medical experts .there is no scientific evidence that the product works **this product is a homeopathic remedy, as such, it has not undergone review on approval by the fda and therefore has not been demonstrated to be safe or effective to diagnose, treat, prevent, mitigate or cure any condition or disease. important: keep this carton for future reference on full labeling. * this product is not manufactured or distributed by matrixx initiatives, inc., owner of the registered trademarks zicam ® cold remedy rapidmelts ® distributed by: topco associates llc elk grove village, il 60007 © topco rara0619 questions? 1-888-423-0139 topcare@topco.com www.topcarebrand.com topcare health cold remedy cherry flavor
Further Questions:
Questions or comments? 1-888-423-0139