MedPath

Bismuth

Drug Facts

Approved
Approval ID

ba4d807b-4c9b-48ba-a8ea-1f6358a825d7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 7, 2025

Manufacturers
FDA

Safecor Health, LLC

DUNS: 828269675

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bismuth subsalicylate

PRODUCT DETAILS

NDC Product Code48433-127
Application NumberM335
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateJune 7, 2025
Generic NameBismuth subsalicylate

INGREDIENTS (11)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
BISMUTH SUBSALICYLATEActive
Quantity: 262 mg in 1 1
Code: 62TEY51RR1
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/11/2022

Package/Label Principal Display Panel

Bismuth Subsalicylate
262 mg
Chewable Tablet
Mfg: Allegiant Health
Exp:02/03/24
Lot22A0016
PKG BY: Safecor Health
Woburn, MA
4843312701

Safecor Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/20/2022

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/11/2022

Active ingredient

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/20/2022

Purpose

Antidiarrheal/Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 6/11/2022

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
  • ringing in the ears or loss of hearing occurs
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/20/2022

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/11/2022

Directions

  • Chew or dissolve in mouth
  • Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ 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 help prevent dehydration caused by diarrhea

Other Information

Phenylketonurics: contains phenylalanine 1.1 mg per tablet
Calcium content per tablet: ·73 mg
• save carton for full directions and warnings
• store at room temperature 15°- 30°C (59°- 86°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/20/2022

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/11/2022

BISMUTH SUBSALICYLATE

262 mg Chewable Tablet
Contains 100 Unit Dose Blisters NDC: 48433-127-01
3 48433 127 10 0
GTIN: 00348433127100
SN: 222202401
Exp: 2024-03-27
Lot: 22A0078
These unit dose packages meet USP specifications for light resistance.
The package design is not child resistant. For institutional use only.
Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 01801

06/2022 PN5728

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Bismuth - FDA Drug Approval Details