FDA.reportPublic FDA data

Pink Bismuth

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:47

Label at a glance#

ProductPink Bismuth
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

relieves upset stomach, heartburn, indigestion, nausea, diarrhea

Dosage and administration

Shake well before use Use pre-measured cup for accurate dosing. mL = mililiter Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed Do not take more than 4 doses 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 by diarrhea

Storage and handling

Each 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg Salicylate 159 mg Keep tightly closed Avoid excessive heat (over 104°F or 40°C) protect from freezing store at room temperature TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

  • relieves upset stomach, heartburn, indigestion, nausea, 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 behavior with nausea and vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.

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

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

Do not use

OTC - DO NOT USE SECTION

if you have

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever, mucus in the stool, a sodium-restricted diet, a magnesium restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • anticoagulation (thinning 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 a 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 this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Use pre-measured cup for accurate dosing. mL = mililiter
  • Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • Do not take more than 4 doses 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 by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • Each 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg
  • Salicylate 159 mg
  • Keep tightly closed
  • Avoid excessive heat (over 104°F or 40°C)
  • protect from freezing
  • store at room temperature
  • TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Upset Stomach Reliever/Antidiarrheal

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

Pink BismuthPink Bismuth

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-047-012020-01-31C16284748780-19d75b9d0-34d5-f424-e053-dadaa90a57ceWe Care Pink Bismuth Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-047-01Pink Bismuth120 mL in 1 BOTTLELIQUID1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-047PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [WE CARE DISTRIBUTOR INC.]2Legacy NDC, 1 package rows20161026_0d049f14-db3b-4ab7-ba97-6574016a6424.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-04770005-047-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
D&C RED NO. 302S42T2808BIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
74ba1350-728d-4035-9502-c823df2be69e0d049f14-db3b-4ab7-ba97-6574016a64242016-10-25WarningsExact identifier
spl id: 74ba1350-728d-4035-9502-c823df2be69e
spl set id: 0d049f14-db3b-4ab7-ba97-6574016a6424

Reported adverse events (FAERS/openFDA)#

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