Estomaquil Polvo

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Estomaquil Polvo
Generic name
BISMUTH SUBSALICYLATE
Manufacturer
ProMex LLC
Product type
HUMAN OTC DRUG
SPL set ID
cf94c99a-c489-45ec-bb13-3e6959e377de
SPL ID
b60909fc-e262-4ad4-bb96-e09b71b38e1c
Version
4
Effective date
2023-11-29
Source export date
2026-10-27
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:23:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.