Stomach Relief Maximum Strength
Bismuth Subsalicylate
Demoulas Super Markets Inc
Human Otc Drug
NDC 53942-558Stomach Relief Maximum Strength also known as Bismuth Subsalicylate is a human otc drug labeled by 'Demoulas Super Markets Inc'. National Drug Code (NDC) number for Stomach Relief Maximum Strength is 53942-558. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Stomach Relief Maximum Strength drug includes Bismuth Subsalicylate - 1050 mg/30mL . The currest status of Stomach Relief Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 53942-558 |
| 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: | Stomach Relief Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Stomach Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum 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: | Bismuth Subsalicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Demoulas Super Markets Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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: | BISMUTH SUBSALICYLATE - 1050 mg/30mL
|
| 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 Oct, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 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: | part335 |
| 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: | Demoulas Super Markets Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308763
|
| 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. |
| NUI: | M0002611
N0000180183
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 62TEY51RR1
|
| 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 EPC: | Bismuth [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Bismuth [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53942-558-26 | 237 mL in 1 BOTTLE (53942-558-26) | 01 Oct, 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:
Purposes bismuth subsalicylate .............. upset stomach reliever and antidiarrheal
Product Elements:
Stomach relief maximum strength bismuth subsalicylate bismuth subsalicylate salicylic acid benzoic acid d&c red no. 22 d&c red no. 28 water saccharin sodium salicylic acid sodium salicylate xanthan gum
Indications and Usage:
Uses relieves â travelers' diarrhea â diarrhea â upset stomach due to overindulgence of food and drink including: â heart burn â indigestion â nausea â gas â belching
Warnings:
Warnings reye's syndrome : children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness.
Do Not Use:
Warnings reye's syndrome : children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness.
When Using:
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Dosage and Administration:
Directions. â shake well before use â use dose cup or tablespoon (tbsp) â adults and children 12 years and over: 1 dose (30 ml or 2 tbsp) every 1 hour as needed â do not exceed 4 doses (120 ml or 8 tbsp) in 24 hours â use until diarrhea stops but not more than 2 days â children under 12 years: ask a doctor â drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Stop Use:
Slop use and ask a doctor if â diarrhea lasts more than 2 days â symptoms get worse or last more than 2 days â ringing in the ears or loss of hearing occurs
Package Label Principal Display Panel:
Principal display panel market basket ® "more for your dollar" *compare to the active ingredient in pepto-bismol⢠maximum strength stomach reliefâ maximum strength bismuth subsalicylate antidiarrheal / upset stomach reliever 5 symptom relief of: ⢠nausea ⢠upset stomach ⢠heartburn ⢠diarrhea ⢠indigestion 8 fl oz (237 ml) tamper evident: do not use if imprinted shrinkband is missing or broken *this product is not manufactured or distributed by procter & gamble, inc., the distributor of pepto-bismol⢠â. distributed by made in usa demoulas supermarkets inc. lr·089 rev01 875 east street tewksbury, ma 01876 0 49705 73076 8 peel here âprincipal display labelâ stomach relief, maximum strength by market basket ® res 53942-558-26 max 8oz
Further Questions:
Questions? 1-877-798-5944