FDA.reportPublic FDA data

Kaopectate

Manufacturer
Kramer Laboratories
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:18

Label at a glance#

ProductKaopectate
Active ingredientBismuth Subsalicylate
Label structure7 sections

Dosage and administration

adults and children 12 years of age and older: 2 chews (1 dose) repeat dose every 1/2 hour to 1 hour as needed do not exceed 8 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (per chew)Purposes
Bismuth subsalicylate 262 mgAnti-diarrheal,
Upset stomach reliever

INDICATIONS & USAGE SECTION

Uses 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

SPL UNCLASSIFIED 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

  • 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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: 2 chews (1 dose)
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 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

SPL UNCLASSIFIED SECTION

  • each soft chew contains: total salicylates 99 mg
  • do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing
  • store at room temperature 20º-25º C (68º-77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water

  

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT TASTE!

FAST & EFFECTIVE RELIEF

Kaopectate®
Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliever

Soft Chews

Diarrhea & Upset Stomach

✓ Begins controlling symptoms from the first dose
✓ Quickly relieves urgency, gas, and cramping
✓ Effective on diarrhea from bacteria, viruses, and other causes

24 Soft Chews
Individually wrapped

Strawberry Flavor

Front Label
Front Label

FAST & EFFECTIVE RELIEF

Do not take maximum dose for more than 2 days per week.

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

502851

Back Label
Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN5
2476644Kaopectate 262 MG Chewable Tablet, Reformulated Aug 2006PSN5
2476644bismuth subsalicylate 262 MG Chewable Tablet [Kaopectate Reformulated Aug 2006]SBD5
308761bismuth subsalicylate 262 MG Chewable TabletSCD5
2476644Kaopectate Reformulated Aug 2006 262 MG Chewable TabletSY5

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
55505-206-69Kaopectate24 in 1 BOTTLETABLET, CHEWABLE245
55505-206-69Kaopectate1 in 1 CARTONTABLET, CHEWABLE15
55505-206-79Kaopectate1 in 1 CARTONTABLET, CHEWABLE15
55505-206-79Kaopectate2 in 1 PACKAGETABLET, CHEWABLE25

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-20655505-206-69, 55505-206-79

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bismuth Subsalicylate62TEY51RR1ACTIB
Calcium CarbonateH0G9379FGKIACT
SucroseC151H8M554IACT
Corn Syrup9G5L16BK6NIACT
Fd&C Red No. 40WZB9127XOAIACT
GlycerinPDC6A3C0OXIACT
Hydrogenated Coconut OilJY81OXM1OMIACT
Lecithin, Soybean1DI56QDM62IACT
Water059QF0KO0RIACT

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 Laboratories2f6766a1-d775-40bf-a039-975ab47fcceb2025-12-19WarningsExact identifier
ndc (package): 55505-206-79
ndc (package): 55505-206-69
ndc (product): 55505-206
ndc11 (package): 55505020669
ndc11 (package): 55505020679
spl id: 6fd63db3-b84f-407f-b656-80f86ad420d1
spl set id: 2f6766a1-d775-40bf-a039-975ab47fcceb

Reported adverse events (FAERS/openFDA)#

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