Drugplain

Pepto Bismol 262 mg/1

Bismuth subsalicylate · TABLET, CHEWABLE · The Procter & Gamble Manufacturing Company

2 Recalls on Record
Plain English

Pepto Bismol is a tablet, chewable containing bismuth subsalicylate at 262 mg/1, taken oral. Manufactured by The Procter & Gamble Manufacturing Company.

Key Facts

Brand Name
Pepto Bismol
Generic Name
Bismuth subsalicylate
NDC Code (Product)
84126-321
Manufacturer
The Procter & Gamble Manufacturing Company
Strength
262 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
12/02/2024

Recall History

2 Recalls on Record
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

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
vomiting340 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: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 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 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.

Frequently Asked Questions

What is Pepto Bismol used for?

Pepto Bismol contains Bismuth subsalicylate. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Pepto Bismol a controlled substance?

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

What is the generic name for Pepto Bismol?

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

What is the NDC code for Pepto Bismol 262 mg/1?

The NDC (National Drug Code) for Pepto Bismol 262 mg/1 is 84126-321, listed by The Procter & Gamble Manufacturing Company.