Kroger Extra Strength
Aluminum Hydroxide And Magnesium Carbonate
The Kroger Co.,
Human Otc Drug
NDC 30142-610Kroger Extra Strength also known as Aluminum Hydroxide And Magnesium Carbonate is a human otc drug labeled by 'The Kroger Co.,'. National Drug Code (NDC) number for Kroger Extra Strength is 30142-610. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Kroger Extra Strength drug includes Aluminum Hydroxide - 160 mg/1 Magnesium Carbonate - 105 mg/1 . The currest status of Kroger Extra Strength drug is Active.
Drug Information:
| Drug NDC: | 30142-610 |
| 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: | Kroger Extra Strength |
| 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: | Aluminum Hydroxide And Magnesium Carbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Kroger Co., |
| 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: | ALUMINUM HYDROXIDE - 160 mg/1
MAGNESIUM CARBONATE - 105 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: | 16 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | THE KROGER CO.,
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1376207
|
| 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: | 0041260385513
|
| UPC stands for Universal Product Code. |
| UNII: | 5QB0T2IUN0
0E53J927NA
|
| 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 |
|---|
| 30142-610-00 | 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (30142-610-00) | 16 May, 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 antacid antacid
Product Elements:
Kroger extra strength aluminum hydroxide and magnesium carbonate aluminum hydroxide aluminum hydroxide magnesium carbonate carbonate ion alginic acid calcium stearate corn syrup sodium bicarbonate starch, corn sucrose rp105 original
Indications and Usage:
Uses relieves ⪠acid indigestion ⪠heartburn ⪠sour stomach ⪠upset stomach associated with these symptoms
Warnings:
Warnings ask a doctor or pharmacist before use if you are ⪠taking a prescription drug. antacids may interact with certain prescription drugs ⪠if you are on a sodium-restricted diet when using this product ⪠do not take more than 16 tablets in 24 hours ⪠do not use the maximum dosage for more than 2 weeks keep out of reach of children. in case of overdose, get medical help or contact a poison control center immediately at 1-800-222-1222.
When Using:
When using this product ⪠do not take more than 16 tablets in 24 hours ⪠do not use the maximum dosage for more than 2 weeks
Dosage and Administration:
Directions ⪠chew 2 to 4 tablets four times a day or as directed by a doctor ⪠take after meals and at bedtime or as needed ⪠for best results follow by a half glass of water or other liquid ⪠do not swallow tablets whole
Package Label Principal Display Panel:
Principal display panel kroger ® ndc 30142-610-00 compare to the active ingredients gaviscon ® extra strength antacid *see back panel antacid tablets extra strength aluminum hydroxide, 160 mg magnesium carbonate, 105 mg fast acting heartburn relief, helps keep acid down for hours our pharmacists recommend 100 chewable tablets original flavor distributed by the kroger co. cincinnati, ohio 45202 quality guarantee 800-632-6900 www.kroger.com gluten free do not use if printed inner seal under cap is broken or missing *gaviscon ® is a registered trademark of glaxosmithkline llc, wilmington, de 19808. glaxosmithkline llc is not affliated with the kroger co. or this product. kroger antacid 100 chewable tablets
Further Questions:
Questions or comments? 1-800-632-6900