Estomaquil Polvo Powder
FDA Label NDC 58988-1080

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Estomaquil Polvo (NDC 58988-1080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, reye`s syndrome, allergy alert, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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:

  • Nausea
  • Heartburn
  • Diarrhea
  • Fullness

    • Maximum Strength

    10 Packets

    Principal Display Panel (10 Packet Carton)

    Principal Display Panel (10 Packet Carton)

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