Bismuth Chewable
Bismuth Subsalicylate 262 Mg
Marc Glassman, Inc.
Human Otc Drug
NDC 68998-046Bismuth Chewable also known as Bismuth Subsalicylate 262 Mg is a human otc drug labeled by 'Marc Glassman, Inc.'. National Drug Code (NDC) number for Bismuth Chewable is 68998-046. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Bismuth Chewable drug includes Bismuth Subsalicylate - 262 mg/1 . The currest status of Bismuth Chewable drug is Active.
Drug Information:
| Drug NDC: | 68998-046 |
| 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: | Bismuth Chewable |
| 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: | Bismuth Subsalicylate 262 Mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Marc Glassman, Inc. |
| 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: | BISMUTH SUBSALICYLATE - 262 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: | 28 Apr, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | 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, 2024 |
| 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: | Marc Glassman, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308761
|
| 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: | 0094442001411
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 68998-046-88 | 30 CELLO PACK in 1 CARTON (68998-046-88) / 1 TABLET, CHEWABLE in 1 CELLO PACK | 28 Apr, 2003 | 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 antidiarrheal/antacid
Product Elements:
Bismuth chewable bismuth subsalicylate 262 mg bismuth subsalicylate salicylic acid aspartame calcium carbonate d&c red no. 27 dextrates magnesium stearate maltodextrin microcrystalline cellulose silicon dioxide rh;046
Indications and Usage:
Uses â controls diarrhea â relieves heartburn, indigestion, nausea and upset stomach
Warnings:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: contains salicylate. do not take if you are â allergic to salicylates (including aspirin) â taking other salicylate products do not use if you have â bloody or black stool â an ulcer â a bleeding problem ask a doctor before use if you have â fever â mucus in the stool ask a doctor or pharmacist before use if you are taking a drug for â anticoagulation (thinning of the blood) â diabetes â gout â arthritis when using this product a temporary but harmless darkening of the stool and/or tongue may occur stop use and ask a doctor if â symptoms get worse â ringing in the ears
Read more...or loss of hearing occurs â diarrhea lasts for more than 2 days pregnancy/breastfeeding ask a health professional before use. keep out of reach of children in case of accidental overdose, contact a doctor or poison control center (1-800-222-1222) immediately.
Do Not Use:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: contains salicylate. do not take if you are â allergic to salicylates (including aspirin) â taking other salicylate products do not use if you have â bloody or black stool â an ulcer â a bleeding problem ask a doctor before use if you have â fever â mucus in the stool ask a doctor or pharmacist before use if you are taking a drug for â anticoagulation (thinning of the blood) â diabetes â gout â arthritis when using this product a temporary but harmless darkening of the stool and/or tongue may occur stop use and ask a doctor if â symptoms get worse â ringing in the ears or loss of hearing occurs â diarrhea lasts for more than 2 days pregnancy/breastfeeding ask a health professional before use. keep out of reach of children in case of accidental overdose, contact a doctor or poison control center (1-800-222-1222) immediately.
When Using:
When using this product a temporary but harmless darkening of the stool and/or tongue may occur
Dosage and Administration:
Directions â drink plenty of clear fluids to help revent deydration caused by diarrhea â adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed â do not exceed 16 tablets in 24 hours â use until diarrhea stops but no more than 2 days â children under 12 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if â symptoms get worse â ringing in the ears or loss of hearing occurs â diarrhea lasts for more than 2 days
Package Label Principal Display Panel:
Principal display panel bismuth bismuth