Dr. Simi Stomach Relief

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

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

Brand name
Dr. Simi Stomach Relief
Generic name
BISMUTH SUBSALICYLATE 525 MG
Manufacturer
Farmacias De Similares TX LLC
Product type
HUMAN OTC DRUG
SPL set ID
4dc9233e-68fb-e1e8-e063-6294a90aee33
SPL ID
4dc9233e-68fc-e1e8-e063-6294a90aee33
Version
1
Effective date
2026-03-24
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:29:21
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 and 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 salicylates (including aspirin) ▪ taking other salicylate products Do not use if you have ▪ an ulcer ▪ a bleeding problem ▪ black or bloody 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 drug for ▪ anticoagulation (thinning of 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 ▪ diarrhea lasts more than 2 days ▪ symptoms get worse or last more than 2 days ▪ ringing in the ears or loss of hearing occurs If pregnant or breast feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.