FDA.reportPublic FDA data

Kaopectate

Manufacturer
KRAMER LABORATORIES
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:43

Label at a glance#

ProductKaopectate
Active ingredientBismuth Subsalicylate
Label structure16 sections

Indications and uses

relieves: traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness

Dosage and administration

shake well immediately before each use only use pre-measured dose cup adults and children 12 years of age and older: 1 dose (30 mL) every hour as needed. do not exceed 4 doses (120 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 30 mL dose cup contains: sodium 13 mg and salicylate 507 mg store at room temperature 20°-25° C (68°-77° F)

Label contents#

Full prescribing information#

Active Ingredient (per 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal
Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

relieves:

  • traveler's 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

OTC - DO NOT USE SECTION

  • 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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

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 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well immediately before each use
  • only use pre-measured dose cup
  • adults and children 12 years of age and older: 1 dose (30 mL) every hour as needed.
  • do not exceed 4 doses (120 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 30 mL dose cup contains: sodium 13 mg and salicylate 507 mg
  • store at room temperature 20°-25° C (68°-77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel, carboxymethylcellulose sodium, FD&C Red No. 40, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA
STRENGTH

2X
THE MEDICINE
PER DOSE

Kaopectate®
Bismuth Subsalicylate 525 mg
● Anti-Diarrheal ● Upset stomach Reliever

Diarrhea &
Upset Stomach

√ Begins controlling symptoms from the first dose
√ Twice the medicine as regular strength Kaopectate
√ Quickly relieves urgency, gas, and cramping

11 fl oz (325 mL)

Peppermint Flavor

682PPT11KA0LB

front
front

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING
Kramer Laboratories, Bridgewater, NJ 08807 1-800-824-4894
K0825        682PPT11KA0LB

Lot:

Exp:

PEEL CORNER TO READ
DRUG FACTS AND INFORMATION

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN1
1043048Kaopectate Extra Strength 525 MG in 15 mL Oral Suspension, Reformulated Aug 2006PSN1
1043048bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]SBD1
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD1
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY1
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY1
1043048Kaopectate 525 MG per 15 ML Oral Suspension, Reformulated Aug 2006SY1
1043048Kaopectate Reformulated Aug 2006 35 MG/ML Oral SuspensionSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-229-64Kaopectate325 mL in 1 BOTTLELIQUID3251

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-22955505-229-64

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
Bismuth Subsalicylate62TEY51RR1ACTIB
CaramelT9D99G2B1RIACT
Carboxymethylcellulose Sodium, UnspecifiedK679OBS311IACT
Fd&C Red No. 40WZB9127XOAIACT
Microcrystalline CelluloseOP1R32D61UIACT
Sodium SalicylateWIQ1H85SYPIACT
Sorbic AcidX045WJ989BIACT
SucroseC151H8M554IACT
Water059QF0KO0RIACT
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
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
ndc (package): 55505-229-64
ndc (product): 55505-229
ndc11 (package): 55505022964
spl id: c7ad4e0a-96fb-4cb5-998d-0b055155eae2
spl set id: 18b79c8c-b2fd-449b-a154-7158c9b13cdd

Reported adverse events (FAERS/openFDA)#

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