SIGNATURE CARE Ultra Strength Stomach

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
SIGNATURE CARE Ultra Strength Stomach
Generic name
BISMUTH SUBSALICYLATE
Manufacturer
SAFEWAY
Product type
HUMAN OTC DRUG
SPL set ID
4b54fa21-d8ea-4497-aa32-17e47669c8e1
SPL ID
4b54fa21-d8ea-4497-aa32-17e47669c8e1
Version
1
Effective date
2026-02-20
Source export date
2026-10-27
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 21:01:15
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 salicylates (including aspirin) ▪ taking other salicylate products Do not use if you have ▪ an ulcer ▪ a bleeding problem ▪ bloody or black stool 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 or last more than 2 days ▪ 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

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