Estomaquil Polvo
Bismuth Subsalicylate
Promex Llc
Human Otc Drug
NDC 58988-1080Estomaquil Polvo also known as Bismuth Subsalicylate is a human otc drug labeled by 'Promex Llc'. National Drug Code (NDC) number for Estomaquil Polvo is 58988-1080. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Estomaquil Polvo drug includes Bismuth Subsalicylate - 262 mg/1 . The currest status of Estomaquil Polvo drug is Active.
Drug Information:
| Drug NDC: | 58988-1080 |
| 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: | Estomaquil Polvo |
| 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: | Promex Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| 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: | 02 Jan, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jun, 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: | ProMex LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1721449
1721455
|
| 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: | 0184125000333
|
| 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 |
|---|
| 58988-1080-1 | 10 POUCH in 1 CARTON (58988-1080-1) / 1 POWDER in 1 POUCH | 02 Jan, 2004 | N/A | No |
| 58988-1080-2 | 20 POUCH in 1 CARTON (58988-1080-2) / 1 POWDER in 1 POUCH | 02 Jan, 2004 | N/A | No |
| 58988-1080-3 | 50 POUCH in 1 CARTON (58988-1080-3) / 1 POWDER in 1 POUCH | 02 Jan, 2004 | 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 upset stomach reliever / antidiarrheal
Product Elements:
Estomaquil polvo bismuth subsalicylate bismuth subsalicylate salicylic acid calcium carbonate citric acid monohydrate magnesium hydroxide sodium bicarbonate tartaric acid
Indications and Usage:
Uses relieves: upset stomach indigestion diarrhea heartburn nausea
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 or vomiting occur, consult a doctor 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 salicylate (including aspirin) taking other salicylate products do not use if you have an ulcer bleeding problem bloody or black stool. ask a doctor before use if you have fever mucus in stool. ask a doctor or pharmacist before use if you are taking any drugs 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 ringing in ears or loss of hearing occurs if diarrhea lasts more than 2 days. if pregnant or breast-feeding , ask a health professi
Read more...onal before use. keep out of the reach of children . in case of overdose, seek professional help or contact a poison control center immediately.
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 or vomiting occur, consult a doctor 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 salicylate (including aspirin) taking other salicylate products do not use if you have an ulcer bleeding problem bloody or black stool. ask a doctor before use if you have fever mucus in stool. ask a doctor or pharmacist before use if you are taking any drugs 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 ringing in ears or loss of hearing occurs if diarrhea lasts more than 2 days. if pregnant or breast-feeding , ask a health professional before use. keep out of the reach of children . in case of overdose, seek professional help or contact a poison control center immediately.
When Using:
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
Dosage and Administration:
Directions adults & children 12 yrs or older: dissolve 2 pouches in 1/2 glass of water. repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period. use until diarrhea stops, but not more than 2 days, if symptoms persist, consult a doctor. drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea. children under 12 yrs ask a doctor.
Stop Use:
Stop use and ask a doctor if symptoms get worse ringing in ears or loss of hearing occurs if diarrhea lasts more than 2 days.
Package Label Principal Display Panel:
Principal display panel - 10 packet carton estomaquil ® relief for: nausea heartburn diarrhea fullness maximum strength 10 packets principal display panel - 10 packet carton