Stomach Relief
Bismuth Subsalicylate
Spirit Pharmaceuticals Llc
Human Otc Drug
NDC 68210-0469Stomach Relief also known as Bismuth Subsalicylate is a human otc drug labeled by 'Spirit Pharmaceuticals Llc'. National Drug Code (NDC) number for Stomach Relief is 68210-0469. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Stomach Relief drug includes Bismuth Subsalicylate - 262 mg/1 . The currest status of Stomach Relief drug is Active.
Drug Information:
| Drug NDC: | 68210-0469 |
| 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 |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Spirit Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| 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 Jun, 2019 |
| 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: | 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: | Spirit Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2121072
|
| 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 |
|---|
| 68210-0469-3 | 1 BOTTLE in 1 CARTON (68210-0469-3) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE | 28 Jun, 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:
Active ingredient purpose (in each softgel) bismuth subsalicylate 262 mg...............upset stomach reliever and anti-diarrheal
Product Elements:
Stomach relief bismuth subsalicylate silicon dioxide yellow wax d&c red no. 33 fd&c yellow no. 6 gelatin glycerin paraffin water lecithin, soybean sorbitol titanium dioxide bismuth subsalicylate salicylic acid 854
Indications and Usage:
Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
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. allergy alert contains salicylate. do not take if you are allergic to salicylates (including aspirin) taking other salicylate products do not use if you have an ulcer a bleeding problem bloody or black stool ask a doctor before use if you have fever mucus in the stool ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout 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 symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days if pregnant or brea
Read more...st feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
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. allergy alert contains salicylate. do not take if you are allergic to salicylates (including aspirin) taking other salicylate products do not use if you have an ulcer a bleeding problem bloody or black stool ask a doctor before use if you have fever mucus in the stool ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout 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 symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Dosage and Administration:
Directions swallow with water, do not chew adults and children 12 years and over: 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea 2 softgels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 softgels) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Stop Use:
Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days
Package Label Principal Display Panel:
Principal display panel valumeds stomach relief bismuth subsalicylate upset stomach reliever / antidiarrheal 5 symptom digestive relief heartburn indigestion nausea upset stomach diarrhea 30 softgels image description
Further Questions:
Questions or comments? 1-888-333-9792