SIGNATURE CARE Ultra Strength Stomach 525 mg/15mL

Bismuth subsalicylate · SUSPENSION · SAFEWAY

No Recall History

Plain English

SIGNATURE CARE Ultra Strength Stomach is a suspension containing bismuth subsalicylate at 525 mg/15mL, taken oral. Manufactured by SAFEWAY.

Key Facts

Brand Name: SIGNATURE CARE Ultra Strength Stomach
Generic Name: Bismuth subsalicylate
NDC Code (Product): 21130-193
Manufacturer: SAFEWAY
Strength: 525 mg/15mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M008
Drug Class: Bismuth [EPC]
Marketing Start: 02/02/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea89 reports

vomiting72 reports

diarrhoea69 reports

abdominal pain56 reports

drug ineffective56 reports

pain53 reports

constipation43 reports

abdominal distension39 reports

off label use37 reports

abdominal pain upper34 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves ▪ travelers’ diarrhea ▪ diarrhea ▪ upset stomach due to overindulgence in food and drink, including: ▪ heartburn ▪ indigestion ▪ nausea ▪ gas ▪ belching ▪ fullness

Dosage & Administration

Directions ▪ shake well before use ▪ only use dose cup provided ▪ adults and children 12 years and over: ▪ 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea ▪ 15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea) ▪ do not exceed 8 doses (120 mL) in 24 hours ▪ use until diarrhea stops but not more than 2 days ▪ children under 12 years: ask a doctor ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

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 1-8…

Frequently Asked Questions

What is SIGNATURE CARE Ultra Strength Stomach used for?

SIGNATURE CARE Ultra Strength Stomach contains Bismuth subsalicylate. It is a suspension taken oral. Consult your doctor for specific uses.

Is SIGNATURE CARE Ultra Strength Stomach a controlled substance?

SIGNATURE CARE Ultra Strength Stomach is not classified as a controlled substance by the DEA.

What is the generic name for SIGNATURE CARE Ultra Strength Stomach?

The generic name for SIGNATURE CARE Ultra Strength Stomach is Bismuth subsalicylate. There are 12 other brand versions of Bismuth subsalicylate.

What is the NDC code for SIGNATURE CARE Ultra Strength Stomach 525 mg/15mL?

The NDC (National Drug Code) for SIGNATURE CARE Ultra Strength Stomach 525 mg/15mL is 21130-193, listed by SAFEWAY.

Product NDC

21130-193

Package NDC

21130-193-12

Other Bismuth Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)