NDC 58988-1080 Estomaquil Polvo
Bismuth Subsalicylate Powder Oral

Product Information

What is NDC 58988-1080?

The NDC code 58988-1080 is assigned by the FDA to the product Estomaquil Polvo which is a human over the counter drug product labeled by Promex Llc. The generic name of Estomaquil Polvo is bismuth subsalicylate. The product's dosage form is powder and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 58988-1080-1 10 pouch in 1 carton / 1 powder in 1 pouch, 58988-1080-2 20 pouch in 1 carton / 1 powder in 1 pouch, 58988-1080-3 50 pouch in 1 carton / 1 powder in 1 pouch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code58988-1080
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Estomaquil Polvo
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Bismuth Subsalicylate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormPowder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Promex Llc
Labeler Code58988
FDA Application Number What is the FDA Application Number?
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.
part335
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-02-2004
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Estomaquil Polvo?


Product Packages

NDC Code 58988-1080-1

Package Description: 10 POUCH in 1 CARTON / 1 POWDER in 1 POUCH

NDC Code 58988-1080-2

Package Description: 20 POUCH in 1 CARTON / 1 POWDER in 1 POUCH

NDC Code 58988-1080-3

Package Description: 50 POUCH in 1 CARTON / 1 POWDER in 1 POUCH

Product Details

What are Estomaquil Polvo Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Estomaquil Polvo Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1721449 - bismuth subsalicylate 262 MG Powder for Oral Suspension
  • RxCUI: 1721455 - Estomaquil 262 MG Powder for Oral Suspension
  • RxCUI: 1721455 - bismuth subsalicylate 262 MG Powder for Oral Suspension [Estomaquil]

Estomaquil Polvo Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Patient Education

Bismuth Subsalicylate

Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)

Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
[Read More]

* Please review the disclaimer below.

Estomaquil Polvo Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



DRUG FACTS


Active Ingredient



Bismuth Subsalicylate: Each pouch contains 262 mg


Purpose



Upset Stomach reliever / Antidiarrheal


Uses



Relieves:

  • upset stomach
  • indigestion
  • diarrhea
  • heartburn
  • nausea

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

Otc - Do Not Use



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.

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any drugs for:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis.

Otc - When Using



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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. In case of overdose, seek professional help or contact a poison control center immediately.


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.

Other Information



  • Avoid excessive heat
  • Each pouch contains: sodium 223mg

Inactive Ingredients



calcium carbonate, citric acid, magnesium hydroxide, sodium bicarbonate, tartaric acid


Principal Display Panel - 10 Packet Carton



ESTOMAQUIL®

Relief for:

* Please review the disclaimer below.