Ultra Stomach Relief 525 mg/15mL

Bismuth subsalicylate · LIQUID · Safeway, Inc.

No Recall History

Plain English

Ultra Stomach Relief is an over-the-counter liquid medicine containing bismuth subsalicylate that you take by mouth to relieve upset stomach, heartburn, and diarrhea. Each dose provides 525 mg of the active ingredient in 15 mL of liquid.

Key Facts

Brand Name: Ultra Stomach Relief
Generic Name: Bismuth subsalicylate
NDC Code (Product): 21130-662
Manufacturer: Safeway, Inc.
Strength: 525 mg/15mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M008
Drug Class: Bismuth [EPC]
Marketing Start: 11/29/2019

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

pain54 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 fullness belching

Dosage & Administration

Directions do not take more than 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea mL = milliliter shake well before using measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product adults and children 12 years and over: 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) children under 12 years of age: ask a doctor

Warnings

Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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 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 diabetes gout arthritis anticoagulation (thinning the blood) 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 childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Ultra Stomach Relief used for?

Is Ultra Stomach Relief a controlled substance?

Ultra Stomach Relief is not classified as a controlled substance by the DEA.

What is the generic name for Ultra Stomach Relief?

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

What is the NDC code for Ultra Stomach Relief 525 mg/15mL?

The NDC (National Drug Code) for Ultra Stomach Relief 525 mg/15mL is 21130-662, listed by Safeway, Inc..

Product NDC

21130-662

Package NDC

21130-662-08

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)