Guardian Pink Bismuth

Manufacturer
Guardian Drug Company
Effective date
2024-12-18
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:44

Label at a glance#

ProductGuardian Pink Bismuth
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Dosage and administration

chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration caused diarrhea

Storage and handling

each tablet contains: sodium less than 1 mg salicylate 102 mg very low sodium avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


PURPOSE

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

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.

 

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

OTC - DO NOT USE SECTION

  • bloody or black stool
  • an ulcer
  • a bleeding problem

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for 


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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

a temporary, but harmless darkening of the stool and/or tongue may occur

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

IF PREGNANT OR BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused diarrhea

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53041-021-41
*Compare to the active ingredient of Pepto-Bismol® 
Pink-Bismuth Tablets

Original Flavor
Bismuth Subsalicylate 
Anti-diarrheal / Upset Stomach Reliever 

Soothing Relief for:

  • Upset stomach
  • Indigestion
  • Nausea
  • Heartburn
  • Diarrhea


30 Chewable Tablets



99
99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN3
308761bismuth subsalicylate 262 MG Chewable TabletSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-021-41Guardian Pink Bismuth6 in 1 BLISTER PACKTABLET, CHEWABLE63
53041-021-41Guardian Pink Bismuth5 in 1 BOXTABLET, CHEWABLE53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-021GUARDIAN PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]3Current NDC, Legacy NDC, 2 package rows20241220_7e83fdf2-4007-46a8-ae9d-eab5a8ff1915.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-02153041-021-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
ndc (package): 53041-021-41
ndc (product): 53041-021
ndc11 (package): 53041002141
spl id: 657ef596-d643-4c06-993d-001a5770cf91
spl set id: 7e83fdf2-4007-46a8-ae9d-eab5a8ff1915

Reported adverse events (FAERS/openFDA)#

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