FDA.reportPublic FDA data

Kaopectate Peppermint Flavor Anti Diarrheal

Manufacturer
Kramer Laboratories
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:12

Label at a glance#

ProductKaopectate Peppermint Flavor Anti Diarrheal
Active ingredientBISMUTH SUBSALICYLATE
Label structure7 sections

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 1/2 hour to 1 hour as needed. do not exceed 8 doses (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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (per 15 mL)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

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

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

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

OTC - ASK DOCTOR SECTION

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

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

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

  • 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 1/2 hour to 1 hour as needed.
    • do not exceed 8 doses (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

SPL UNCLASSIFIED SECTION

  •  each 15 mL dose cup contains: sodium 6 mg and salicylate 135mg
  •  store at room temperature 20º-25º C (68º-77º F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW IMPROVED TASTE!

Kaopectate®
Bismuth Subsalicylate 262 MG
• Anti-Diarrheal • Upset Stomach Reliever

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

11 fl oz (325mL)

Peppermint Flavor

681PPT11KA0 F

Front Label
Front Label

Kaopectate Peppermint 11 oz

Do not use if inner seal is broken
or missing

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

Lot:

Exp:

PEEL CORNER TO READ COMPLETE
DRUG FACTS AND INFORMATION

681PPT11KA0LB

Back Label
Back Label

   

  

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN6
642346Kaopectate 262 MG in 15 mL Oral Suspension, Reformulated Aug 2006PSN6
642346bismuth subsalicylate 17.5 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]SBD6
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD6
308762bismuth subsalicylate 1.75 % Oral SuspensionSY6
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY6
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY6
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY6
642346Kaopectate 262 MG per 15 ML Oral Suspension, Reformulated Aug 2006SY6
642346Kaopectate Reformulated Aug 2006 17.5 MG/ML Oral SuspensionSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix0070907-02labelback.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-199-36Kaopectate Peppermint Flavor Anti Diarrheal236 mL in 1 BOTTLELIQUID2366
55505-199-64Kaopectate Peppermint Flavor Anti Diarrheal325 mL in 1 BOTTLELIQUID3256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-199-64ML - Milliliter55505-1995effe60a-376b-4b22-a1a4-3e7e77452fe212026-02-05

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
55505-19955505-199-36, 55505-199-64

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
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
Kaopectate Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratories0316f469-e9fa-47c3-bb20-bd4588b40bcc2025-12-19WarningsExact identifier
ndc (package): 55505-199-64
ndc (package): 55505-199-36
ndc (product): 55505-199
ndc11 (package): 55505019936
ndc11 (package): 55505019964
spl id: 7661cb13-fcaa-4bbe-a803-8ecb666550d7
spl set id: 0316f469-e9fa-47c3-bb20-bd4588b40bcc

Reported adverse events (FAERS/openFDA)#

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