FDA.reportPublic FDA data

QC Pink Bismuth Subsalicylate 262mg 30 Chewable Tablets

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:04

Label at a glance#

ProductQC Pink Bismuth Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

▪ chew completely or dissolve tablets in mouth. ▪ adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed ▪ do not exceed 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 clear fluids to help prevent dehydration caused by diarrhea.

Storage and handling

▪ each tablet contains: salicylate 102 mg ▪ store at room temperature. ▪ avoid excessive heat ▪ keep this carton for future reference on full labeling TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

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
  • nausea
  • gas
  • belching
  • fullness

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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 a doctor if

OTC - STOP USE SECTION

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
If pregnant or breast-feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed
  • do not exceed 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 clear fluids to help prevent dehydration caused by diarrhea.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat
  • keep this carton for future reference on full labeling

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

Questions?

OTC - QUESTIONS SECTION

248-449-9300

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC# 63868-421-30

Compare to the active ingredient in PEPTO-BISMOL®

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262 mg

Soothing Relief for: Upset stomach, Indigestion, Nausea, Heartburn, Diarrhea

Original Flavor

30 Chewable Tablets

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 INC., the distributor of Pepto-Bismol®

Quality Choice Pink Bismuth 30 Chewable Tablets
Quality Choice Pink Bismuth 30 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN1
308761bismuth subsalicylate 262 MG Chewable TabletSCD1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-421-302022-01-28C16284748780-1d6a99b39-d499-a426-e053-dadaa90af4c2QC Pink Bismuth Subsalicylate 262mg 30 Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-421-30QC Pink BismuthStomach Relief5 in 1 CARTONTABLET, CHEWABLE51
63868-421-30QC Pink BismuthStomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-421QC PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [CHAIN DRUG MARKETING ASSOCIATION]1Legacy NDC, 2 package rows20200320_a6ce7a58-bdbf-472d-af2f-014b07f12266.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-42163868-421-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 272LRS185U6KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
a6ce7a58-bdbf-472d-af2f-014b07f12266a6ce7a58-bdbf-472d-af2f-014b07f122662020-03-19WarningsExact identifier
spl id: a6ce7a58-bdbf-472d-af2f-014b07f12266
spl set id: a6ce7a58-bdbf-472d-af2f-014b07f12266

Reported adverse events (FAERS/openFDA)#

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