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Estomaquil polvo - Medication Information

Product NDC Code 58988-1080
Drug Name

Estomaquil polvo

Type Brand
Active Ingredients
Bismuth subsalicylate 262 mg/1
Route ORAL
Dosage Form POWDER
RxCUI drug identifier 1721449,
1721455
Application Number M008
Labeler Name ProMex LLC
Packages
Package NDC Code Description
58988-1080-1 10 pouch in 1 carton (58988-1080-1) / 1 powder in 1 pouch
58988-1080-2 20 pouch in 1 carton (58988-1080-2) / 1 powder in 1 pouch
58988-1080-3 50 pouch in 1 carton (58988-1080-3) / 1 powder in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each pouch) Bismuth Subsalicylate 262 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves: travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Purpose

Information about the drug product’s indications for use.
Purpose Upset stomach reliever / Antidiarrheal

Spl product data elements

Usually a list of ingredients in a drug product.
Estomaquil Polvo BISMUTH SUBSALICYLATE BISMUTH SUBSALICYLATE SALICYLIC ACID CALCIUM CARBONATE CITRIC ACID MONOHYDRATE MAGNESIUM HYDROXIDE SODIUM BICARBONATE TARTARIC ACID MALTODEXTRIN SILICON DIOXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton ESTOMAQUIL ® Bismuth Subsalicylate 262 mg Relief for: Nausea Heartburn Diarrhea Fullness Maximum Strength 10 Pouches 0.1 oz (3.0 g) Each Principal Display Panel - 3.0 g Pouch Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Distributed By: PRO-MEX ® P.O. Box 63-0716 Miami, FL. 33163

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have fever mucus in the stool

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood) diabetes gout arthritis

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have an ulcer a bleeding problem

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of the reach of children. In case of overdose, seek professional help or contact a poison control center immediately

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information each pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg avoid excessive heat

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 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 salicylate (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem 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 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 the reach of children. In case of overdose, seek professional help or contact a poison control center immediately

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API