Bismuth Subsalicylate 262 mg

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2022-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:54:33

Label at a glance#

ProductBismuth Subsalicylate 262 mg
Active ingredientBISMUTH SUBSALICYLATE
Label structure20 sections

Indications and uses

• controls diarrhea • relieves upset stomach due to overindulgence in food or drink

Dosage and administration

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • repeat dosage every 1/2 to 1 hour as needed • do not take more than 8 doses in 24 hours • use until diarrhea stops but not more than 2 days • adults and children 12 years and over: 2 tablets • children under 12 years: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal / Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink

Warnings

WARNINGS SECTION

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Contains salicylates. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

OTC - DO NOT USE SECTION

Do not use

  • if you have bloody or black stool
  • if you have an ulcer or bleeding problem

Drug Facts continued on back of label

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Relabeled By: Preferred Pharmaceuticals Inc.

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-8128-3

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

Bismuth Subsalicylate Tablets 262mg
Bismuth Subsalicylate Tablets 262mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-029-03EA - Each69618-0292346e47b-3b4e-455a-883c-927f7f93195b12016-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-812868788-8128-3
69618-029

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEReliable 1 Laboratories LLC2e40ffd8-1afa-43af-e054-00144ff8d46c2025-01-15WarningsExact identifier
ndc (product): 69618-029
41adb86b-c4dd-40c4-9b4b-5e69cea0a3d6a8f6bd6f-e972-434e-b0de-ab65b67a1ce42024-01-15WarningsExact identifier
spl set id: a8f6bd6f-e972-434e-b0de-ab65b67a1ce4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.