FDA.reportPublic FDA data

Kaopectate Max Peppermint Flavor Anti Diarrheal

Manufacturer
Kramer Laboratories
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:32

Label at a glance#

ProductKaopectate Max 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 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (per 15 mL)Purposes
Bismuth subsalicylate 525 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 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

SPL UNCLASSIFIED SECTION

  •  each 15 mL dose cup contains: sodium 10 mg
  •  do not use if inner seal is broken or missing
  •  store at room temperature 20º-25º C (68º-77º F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kaopectate®
Bismuth Subsalicylate

• Anti-Diarrheal • Upset Stomach Reliever

MAX

Diarrhea & 
Upset Stomach

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

8 fl oz (236 mL)

Peppermint Flavor

200H130

front panel
front panel

Peel

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

LOT EXP

P003H12000

rear panel
rear panel

   

  

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN5
1043048Kaopectate Extra Strength 525 MG in 15 mL Oral Suspension, Reformulated Aug 2006PSN5
1043048bismuth subsalicylate 35 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]SBD5
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD5
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY5
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY5
1043048Kaopectate 525 MG per 15 ML Oral Suspension, Reformulated Aug 2006SY5
1043048Kaopectate Reformulated Aug 2006 35 MG/ML Oral SuspensionSY5

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 Matrix0070904-02Max_Peppermint_front.jpg
Data codeData Matrix0070907-02Max_Peppermint_back.jpg

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
55505-200-36Kaopectate Max Peppermint Flavor Anti Diarrheal236 mL in 1 BOTTLELIQUID2365

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
55505-20055505-200-36

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, Unspecified FormK679OBS311IACT
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 Max Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratoriese7218045-a593-485b-a5ba-03f3b35cbec42025-12-19WarningsExact identifier
ndc (package): 55505-200-36
ndc (product): 55505-200
ndc11 (package): 55505020036
spl id: 28b8a7d7-e01a-4db1-8284-bf48d914eca9
spl set id: e7218045-a593-485b-a5ba-03f3b35cbec4

Reported adverse events (FAERS/openFDA)#

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