Drugplain

Pepto Bismol Ultra 525 mg/15mL

Bismuth subsalicylate · SUSPENSION · The Procter & Gamble Manufacturing Company

No Recall History
Plain English

Pepto Bismol Ultra is an over-the-counter oral suspension containing bismuth subsalicylate that is used to relieve symptoms of indigestion, heartburn, and diarrhea. Each 15 mL dose contains 525 mg of the active ingredient bismuth subsalicylate.

Key Facts

Brand Name
Pepto Bismol Ultra
Generic Name
Bismuth subsalicylate
NDC Code (Product)
69423-966
Manufacturer
The Procter & Gamble Manufacturing Company
Strength
525 mg/15mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
03/07/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

chronic kidney disease1,414 reports
acute kidney injury814 reports
renal failure715 reports
diarrhoea617 reports
nausea536 reports
end stage renal disease452 reports
vomiting339 reports
fatigue333 reports
renal injury327 reports
gastrooesophageal reflux disease298 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 swallow with water, do not chew adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (8 caplets) 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 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

Frequently Asked Questions

What is Pepto Bismol Ultra used for?

Pepto Bismol Ultra is an over-the-counter oral suspension containing bismuth subsalicylate that is used to relieve symptoms of indigestion, heartburn, and diarrhea. Each 15 mL dose contains 525 mg of the active ingredient bismuth subsalicylate.

Is Pepto Bismol Ultra a controlled substance?

Pepto Bismol Ultra is not classified as a controlled substance by the DEA.

What is the generic name for Pepto Bismol Ultra?

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

What is the NDC code for Pepto Bismol Ultra 525 mg/15mL?

The NDC (National Drug Code) for Pepto Bismol Ultra 525 mg/15mL is 69423-966, listed by The Procter & Gamble Manufacturing Company.

Product NDC

69423-966

Package NDC

69423-966-12

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

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