Ultra Strength Antacid Peppermint Flavored
Calciium Carbonate
Target Corporation
Human Otc Drug
NDC 11673-813Ultra Strength Antacid Peppermint Flavored also known as Calciium Carbonate is a human otc drug labeled by 'Target Corporation'. National Drug Code (NDC) number for Ultra Strength Antacid Peppermint Flavored is 11673-813. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Ultra Strength Antacid Peppermint Flavored drug includes Calcium Carbonate - 1000 mg/1 . The currest status of Ultra Strength Antacid Peppermint Flavored drug is Active.
Drug Information:
| Drug NDC: | 11673-813 |
| 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: | Ultra Strength Antacid Peppermint Flavored |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Ultra Strength Antacid |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Peppermint Flavored |
| 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: | Calciium Carbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Target Corporation |
| 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 - 1000 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: | 15 Mar, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | Target Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308892
|
| 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: | 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 |
|---|
| 11673-813-47 | 160 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (11673-813-47) | 15 Mar, 2018 | 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:
Ultra strength antacid peppermint flavored calciium carbonate calcium carbonate carbonate ion calcium cation dextrose, unspecified form magnesium stearate maltodextrin starch, corn sucralose rp103
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 7 tablets in 24 hours ⢠if pregnant do not take more than 5 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 2-3 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:
Package/label principal display panel ndc 11673-813-47 *compare to tums® ultra* ultra strength antacid 1000 calcium carbonate fast relief of upset stomach, heartburn and acid indigestion. 160 tablets mint flavor naturally and artificially flavored k parave 160 chewable tablets gluten free distributed by target corporation minneapolis, mn 55403 tm & ©2019 target brands, inc. *this product is not manufactured or distributed by glaxosmithkline llc, owner of the registered trademark, ultra strength tums®. safety sealed: do not use if printed seal under cap is torn or missing up and up ultra strength 160 chewable tablets mint flavor
Further Questions:
Questions? 1-866-467-2748