FDA.reportPublic FDA data

Anti-Diarrheal

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:00

Label at a glance#

ProductAnti-Diarrheal
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Indications and uses

relieves: indigestion nausea heartburn diarrhea upset stomach associated with these symptoms

Dosage and administration

swallow caplet(s) with water, do not chew adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed do not take more than 8 doses (16 caplets) 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 caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg very low sodium store at 59°-77°F (15°-25°C), in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

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

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

SPL UNCLASSIFIED SECTION

Contains salicylate. Do not take if you are

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

OTC - DO NOT USE SECTION

Do not use if you have

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

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 of 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.

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

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 caplets) 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 caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • store at 59°-77°F (15°-25°C), in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

SPL UNCLASSIFIED SECTION

Product distributed by: Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
⋆ GUARANTEED ⋆

Anti-
Diarrheal

Bismuth subsalicylate 262 mg

Upset Stomach Reliever/
Anti-diarrheal

  • Relieves the Symptoms
    of Diarrhea

ACTUAL SIZE

24
Caplets

Lil'
Drug Store ®

PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton
PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN3
308760bismuth subsalicylate 262 MG Oral TabletSCD3

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
66715-6841-4Anti-Diarrheal1 in 1 CARTONTABLET13
66715-6841-4Anti-Diarrheal24 in 1 BOTTLE, PLASTICTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6841ANTI-DIARRHEAL (BISMUTH SUBSALICYLATE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20241127_079901b3-393b-44f0-85c9-2d8911f2a42a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-684166715-6841-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 272LRS185U6KIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

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
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
ndc (package): 66715-6841-4
ndc (product): 66715-6841
ndc11 (package): 66715684104
spl id: 27c3b3bd-50fc-cd26-e063-6394a90ab634
spl set id: 079901b3-393b-44f0-85c9-2d8911f2a42a

Reported adverse events (FAERS/openFDA)#

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