Drugplain

Bismuth 262 mg/1

Bismuth subsalicylate · TABLET · Allegiant Health

4 Recalls on Record
Plain English

Bismuth is a tablet containing bismuth subsalicylate at 262 mg/1, taken oral. Manufactured by Allegiant Health.

Key Facts

Brand Name
Bismuth
Generic Name
Bismuth subsalicylate
NDC Code (Product)
69168-046
Manufacturer
Allegiant Health
Strength
262 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
12/23/2014

Recall History

4 Recalls on Record
Class II03/25/2019

Lohxa LLC

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 00093746556, Pedigree: AD42592_7, EXP: 5/14/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea156 reports
vomiting130 reports
abdominal pain107 reports
diarrhoea105 reports
off label use101 reports
abdominal distension90 reports
constipation87 reports
drug ineffective86 reports
dyspnoea81 reports
ascites78 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 chew or dissolve in mouth Adults and children over 12 years : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor drink plenty of clear fluids to 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 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 n diarrhea lasts more than 2 days When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur If pregnant or breast-feeding ask a health professional before use.

Frequently Asked Questions

What is Bismuth used for?

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

Is Bismuth a controlled substance?

Bismuth is not classified as a controlled substance by the DEA.

What is the generic name for Bismuth?

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

What is the NDC code for Bismuth 262 mg/1?

The NDC (National Drug Code) for Bismuth 262 mg/1 is 69168-046, listed by Allegiant Health.

Product NDC

69168-046

Package NDC

69168-046-32

Other Bismuth Brands

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

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