Winco Foods Antacid Regular Strength
Calcium Carbonate
Winco Foods, Llc
Human Otc Drug
NDC 67091-357Winco Foods Antacid Regular Strength also known as Calcium Carbonate is a human otc drug labeled by 'Winco Foods, Llc'. National Drug Code (NDC) number for Winco Foods Antacid Regular Strength is 67091-357. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Winco Foods Antacid Regular Strength drug includes Calcium Carbonate - 500 mg/1 . The currest status of Winco Foods Antacid Regular Strength drug is Active.
Drug Information:
| Drug NDC: | 67091-357 |
| 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: | Winco Foods Antacid Regular Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Winco Foods Antacid |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Regular Strength |
| 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: | Calcium Carbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Winco Foods, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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: | CALCIUM CARBONATE - 500 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: | 25 Feb, 2020 |
| 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. |
| Application Number: | part331 |
| 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, 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: | WINCO FOODS, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308907
|
| 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. |
| UPC: | 0070552241428
|
| UPC stands for Universal Product Code. |
| UNII: | H0G9379FGK
|
| 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 |
|---|
| 67091-357-15 | 150 TABLET, CHEWABLE in 1 BOTTLE (67091-357-15) | 25 Feb, 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 antacid
Product Elements:
Winco foods antacid regular strength calcium carbonate calcium carbonate carbonate ion calcium cation dextrose, unspecified form magnesium stearate maltodextrin starch, corn sucralose rp101
Indications and Usage:
Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Warnings:
Warnings ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescription drugs. when using this product do not take more than 15 tablets in 24 hours if pregnant do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor keep out of reach of children.
When Using:
When using this product do not take more than 15 tablets in 24 hours if pregnant do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Dosage and Administration:
Directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor. do not swallow tablets whole. do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
Package Label Principal Display Panel:
Principal display panel winco ® foods ndc# 67091-357-15 compare to the active ingredient in tums ® regular strength antacid regular strength calcium carbonate 500mg/antacid fast relief of acid indigestion, heartburn and upset stomach peppermint naturally and artificially flavored 150 chewable tablets gluten free k pareve distributed by: winco foods, llc boise, id 83704 * this product is not manufactured or distributed by glaxosmithkline llc, owner of the registered trademark, tums ® regular strength. winco foods regular strength peppermint 150 counts
Further Questions:
Questions? call 1-800-824-1706 safety sealed: do not use if printed seal under cap is torn or missing.