Quantum Health Bing Cherry Flavor
Menthol, Unspecified Form
Quantum, Inc.
Human Otc Drug
NDC 70084-610Quantum Health Bing Cherry Flavor also known as Menthol, Unspecified Form is a human otc drug labeled by 'Quantum, Inc.'. National Drug Code (NDC) number for Quantum Health Bing Cherry Flavor is 70084-610. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Quantum Health Bing Cherry Flavor drug includes Menthol, Unspecified Form - 5 mg/1 . The currest status of Quantum Health Bing Cherry Flavor drug is Active.
Drug Information:
| Drug NDC: | 70084-610 |
| 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: | Quantum Health Bing Cherry Flavor |
| 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: | Menthol, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Quantum, Inc. |
| 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: | MENTHOL, UNSPECIFIED FORM - 5 mg/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: | OTC MONOGRAPH FINAL |
| 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: | 01 May, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 2026 |
| 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. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Quantum, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311508
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 70084-610-18 | 18 LOZENGE in 1 BAG (70084-610-18) | 01 May, 2017 | 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:
Purposes antitussive (cough suppressant) / oral anesthetic
Product Elements:
Quantum health bing cherry flavor menthol, unspecified form menthol, unspecified form menthol, unspecified form brown rice sucrose honey ulmus rubra bark beet juice sour cherry dark red-brown p bing cherry
Indications and Usage:
Uses temporarily relieves: cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants, occasional minor irritation, pain, sore mouth, and sore throat.
Warnings:
Warnings sore throat warning severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 5 years of age unless directed by a physician. ask a doctor before use if you have persistent or chronic cough as occurs with smoking, asthma, or emphysema. cough that occurs with excessive phlegm (mucus). stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. sore mouth symptoms do not improve in 7 days. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children.
Dosage and Administration:
Directions adults and children 5 years and over: dissolve lozenge slowly in the mouth. repeat every 2 hours as needed or as directed by a doctor. children under 5 years of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. sore mouth symptoms do not improve in 7 days.
Package Label Principal Display Panel:
Principal display panel - 18 lozenge bag great taste quantum ® health cough relief lozenges natural menthol cough suppressant oral anesthetic bing cherry flavor made with bing cherry juice provides soothing relief usda organic 18 lozenges actual size principal display panel - 18 lozenge bag