FDA.reportPublic FDA data

QC Quality Choice Pink Bismuth Stomach Relief

Manufacturer
Chain Drug Manufacturing Assn
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:11

Label at a glance#

ProductQC Quality Choice Pink Bismuth Stomach Relief
Active ingredientBismuth subsalicylate
Label structure9 sections

Indications and uses

relieves ▪ Travelers ’diarrhea ▪ diarrhea ▪ upset stomach due to overindulgence in food and drink, including: ▪ heartburn ▪ indigestion ▪ upset stomach ▪ nausea ▪ gas ▪ belching

Dosage and administration

▪ shake well before use ▪ for accurate dosing, use dose cup ▪ adults and children 12 years and over: 1 dose (2 tbsp or 30 ml) every 1 hour as needed ▪ do not exceed 8 doses (16 tbsp. or 240 ml) 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 tbsp contains: sodium 6 mg ▪ low sodium ▪ sugar free ▪ salicylate 130 mg ▪ protect from freezing ▪ avoid excessive heat (more than 104°F or 40°C) ▪ TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each 15 ml Tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • Travelers ’diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • upset stomach
  • nausea
  • gas
  • belching

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have

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

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
  • 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

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over:
    1 dose (2 tbsp or 30 ml) every 1 hour as needed
  • do not exceed 8 doses (16 tbsp. or 240 ml) 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 tbsp contains: sodium 6 mg
    • low sodium
    • sugar free
    • salicylate 130 mg
    • protect from freezing
    • avoid excessive heat (more than 104°F or 40°C)
  • TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide ,potassium sorbate, purified water, red 22,red 28, salicylic acid, simethicone emulsion, sodium benzoate ,sucralose, xanthan gum

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC

Quality Choice®

NDC 63868-303-12

Compare to the active ingredient in PEPTO-BISMOL®Regular Strength

PINK BISMUTH

Stomach Relief

Bismuth Subsalicylate 262mg

Soothing Relief from:

  • Upset Stomach
  • Indigestion Nausea
  • Heartburn
  • Diarrhea
  • ORIGINAL FLAVOR

12 FL OZ (354 mL)

QC SATISFACTION GUARANTEED

©Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Procter & Gamble, distributors of Pepto-Bismol®.

Quality Choice Pink Bismuth Stomach Relief Original Flavor 12 FL OZ 354 mL
Quality Choice Pink Bismuth Stomach Relief Original Flavor 12 FL OZ 354 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN3
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-303-122024-01-30C16284748780-1ba0f9c33-466e-a910-e053-dadaa90a0b85QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL
63868-303-122022-01-18C16284748780-1ba0f9c33-466e-a910-e053-dadaa90a0b85QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL
63868-303-122021-01-29C16284748780-1ba0f9c33-466e-a910-e053-dadaa90a0b85QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-303-12QC Quality Choice Pink Bismuth Stomach Relief354 mL in 1 BOTTLE, PLASTICSUSPENSION3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-303QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CHAIN DRUG MANUFACTURING ASSN]3Legacy NDC, 1 package rows20220119_bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-303-08ML - Milliliter63868-3039e8fd258-6432-4098-9494-71fc7a2b072712024-05-16
63868-303-12ML - Milliliter63868-30320d2a458-ff0b-4c5f-aaf9-964af321130712024-07-12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-30363868-303-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bismuth subsalicylate62TEY51RR1ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
D&C red no. 221678RKX8RTIACT
D&C red no. 28767IP0Y5NHIACT
salicylic acidO414PZ4LPZIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
032234ec-de62-42ca-ba2e-b6ec9154c789bbb7ddea-c8fd-4f81-b5b5-3b6038c5e5722022-01-18WarningsExact identifier
spl id: 032234ec-de62-42ca-ba2e-b6ec9154c789
spl set id: bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572

Reported adverse events (FAERS/openFDA)#

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