Zicam Ultra Cold Remedy Rapidmelts

Zinc Acetate Anhydrous And Zinc Gluconate


Matrixx Initiatives, Inc.
Human Otc Drug
NDC 62750-084
Zicam Ultra Cold Remedy Rapidmelts also known as Zinc Acetate Anhydrous And Zinc Gluconate is a human otc drug labeled by 'Matrixx Initiatives, Inc.'. National Drug Code (NDC) number for Zicam Ultra Cold Remedy Rapidmelts is 62750-084. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Zicam Ultra Cold Remedy Rapidmelts drug includes Zinc Acetate Anhydrous - 2 [hp_X]/1 Zinc Gluconate - 1 [hp_X]/1 . The currest status of Zicam Ultra Cold Remedy Rapidmelts drug is Active.

Drug Information:

Drug NDC: 62750-084
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: Zicam Ultra Cold Remedy Rapidmelts
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 Acetate Anhydrous And Zinc Gluconate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Matrixx Initiatives, Inc.
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 ACETATE ANHYDROUS - 2 [hp_X]/1
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: 15 Jun, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 30 Sep, 2023
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: 05 May, 2026
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:Matrixx Initiatives, Inc.
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:H2ZEY72PME
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
62750-084-101 BOTTLE, PLASTIC in 1 CARTON (62750-084-10) / 18 TABLET in 1 BOTTLE, PLASTIC15 Jun, 201930 Sep, 2023No
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 reduces duration and severity of the common cold

Product Elements:

Zicam ultra cold remedy rapidmelts zinc acetate anhydrous and zinc gluconate zinc acetate anhydrous zinc cation zinc gluconate zinc cation crospovidone (120 .mu.m) magnesium stearate mannitol ammonium glycyrrhizate sodium starch glycolate type a potato stearic acid sucralose z

Indications and Usage:

Uses reduces duration of the common cold helps reduce severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion zicam ® ultra cold remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Warnings:

Warnings ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur if pregnant or breast-feeding, ask a 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.

Dosage and Administration:

Directions for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: take 1 tablet at the onset of symptoms dissolve entire tablet in mouth. do not chew. do not swallow whole. repeat every 2 – 3 hours, not to exceed 7 tablets in 24 hours. take 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. children under 12 years of age: ask a doctor before use

Stop Use:

Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

Package Label Principal Display Panel:

Principal display panel - 18 tablet bottle carton ndc 62750-084-10 zicam ® cold remedy shortens colds ultra free of artificial dyes the pre-cold ® medicine take at the first sign of a cold clinically proven to shorten colds rapidmelts ® orange cream flavor 18 quick dissolve tablets homeopathic principal display panel - 18 tablet bottle carton

Further Questions:

Questions? comments? side effects? call 877-942-2626 toll free


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.