FDA.reportPublic FDA data

Pink Bismuth Chewable Tablets

Manufacturer
Discount Drug Mart, Inc | Guardian Drug Company
Effective date
2025-02-27
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:19

Label at a glance#

ProductPink 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 clear 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:

  • heartburn
  • indigestion
  • nausea
  • upset stomach
  • diarrhea


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 behaviour 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 clear 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

*Compare to the Active Ingredient in Pepto-Bismol®


DISCOUNT drug mart

FOOD FAIR


Pink Bismuth Tablets


Soothing Relief For:

  • Upset stomach
  • Indigestion
  • Nausea
  • Heartburn
  • Diarrhea

 
30 Chewable Tablets



122-30-ddm.jpg
122-30-ddm.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN2
308761bismuth subsalicylate 262 MG Chewable TabletSCD2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-122-35Pink Bismuth6 in 1 BLISTER PACKTABLET, CHEWABLE62
53943-122-35Pink Bismuth5 in 1 BOXTABLET, CHEWABLE52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-122PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [DISCOUNT DRUG MART, INC]2Current NDC, 2 package rows20250302_2e0ce5dd-9eb5-8568-e063-6394a90a1a29.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
53943-12253943-122-35

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
STARCH, CORNO8232NY3SJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0ce5dd-9eb5-8568-e063-6394a90a1a292025-02-27WarningsExact identifier
ndc (package): 53943-122-35
ndc (product): 53943-122
ndc11 (package): 53943012235
spl id: 5ab81570-758a-4451-b621-7ac6172815e5
spl set id: 2e0ce5dd-9eb5-8568-e063-6394a90a1a29

Reported adverse events (FAERS/openFDA)#

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