FDA.reportPublic FDA data

Kaopectate Cherry Flavor Anti Diarrheal

Manufacturer
Kramer Laboratories | Trillium Health Care Products Inc.
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:30

Label at a glance#

ProductKaopectate Cherry 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 ½ 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

Warnings

WARNINGS SECTION

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 ½ 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 9 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

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

8 fl oz (236 mL)

Cherry Flavor

201H140 

Front Label Image
Front Label Image

Peel

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

LOT EXP

P013H16000

Rear Label Image
Rear Label Image

   

  

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
55505-20155505-201-36

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
ea6acf69-6aab-4c33-b53c-66cfa1112d60bff5ff79-174d-441d-969c-7f0f74e2ef4e2023-12-20WarningsExact identifier
spl set id: bff5ff79-174d-441d-969c-7f0f74e2ef4e

Reported adverse events (FAERS/openFDA)#

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