Kaopectate - DailyMed Details

Kaopectate

SPL v1

SPL

SPL Set ID 18b79c8c-b2fd-449b-a154-7158c9b13cdd

Route

ORAL

Published

Effective Date 2025-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 mg)

Inactive Ingredients

Caramel Carboxymethylcellulose Sodium, Unspecified Fd&c Red No. 40 Microcrystalline Cellulose Sodium Salicylate Sorbic Acid Sucrose Water Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-02-01

Description

Bismuth subsalicylate 525 mg

Purpose

Anti-diarrheal Upset stomach reliever

Medication Information

Purpose

Anti-diarrheal Upset stomach reliever

Description

Bismuth subsalicylate 525 mg

Uses

relieves:

traveler's diarrhea
diarrhea
upset stomach due to overindulgence in food and drink

including:

heartburn
indigestion
nausea
gas
belching
fullness

Purposes

Anti-diarrheal

Upset stomach reliever

Warnings

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.

Directions

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

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

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

Do Not Take If You Are

allergic to salicylates (including aspirin)
taking other salicylate products

Do Not Use If You Have

an ulcer
a bleeding problem
bloody or black stool

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

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

When Using This Product

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop Use and Ask A Doctor If

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

Active Ingredient (per 15 Ml)

Bismuth subsalicylate 525 mg

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

a sodium-restricted diet
fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

diabetes
gout
arthritis
anticoagulation (thinning the blood)

Structured Label Content

Uses

relieves:

traveler's diarrhea
diarrhea
upset stomach due to overindulgence in food and drink

including:

heartburn
indigestion
nausea
gas
belching
fullness

Purposes

Anti-diarrheal

Upset stomach reliever

Warnings

Directions

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 (Other information)

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 ingredients)

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

Do Not Take If You Are (Do not take if you are)

allergic to salicylates (including aspirin)
taking other salicylate products

Do Not Use If You Have (Do not use if you have)

an ulcer
a bleeding problem
bloody or black stool

Principal Display Panel

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

When Using This Product (When using this product)

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

Active Ingredient (per 15 Ml) (Active Ingredient (per 15 mL))

Bismuth subsalicylate 525 mg

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a sodium-restricted diet
fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

diabetes
gout
arthritis
anticoagulation (thinning the blood)

Advanced Ingredient Data

[{"name": "Bismuth Cation", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "525", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Caramel", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Carboxymethylcellulose Sodium, Unspecified", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Fd&C Red No. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Microcrystalline Cellulose", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Salicylate", "unii": "WIQ1H85SYP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbic Acid", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sucrose", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Xanthan Gum", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves: traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness", "Purposes": "Anti-diarrheal Upset stomach reliever", "Warnings": "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.", "Directions": "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": "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": "caramel, carboxymethylcellulose sodium, FD&C Red No. 40, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum", "Do not take if you are": "allergic to salicylates (including aspirin) taking other salicylate products", "Do not use if you have": "an ulcer a bleeding problem bloody or black stool", "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 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", "When using this product": "a temporary, but harmless, darkening of the stool and/or tongue may occur", "Stop use and ask a doctor if": "symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days", "Active Ingredient (per 15 mL)": "Bismuth subsalicylate 525 mg", "If pregnant or breast-feeding": "ask a health professional before use.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "a sodium-restricted diet fever mucus in the stool", "Ask a doctor or pharmacist before use if you are": "taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.025481 · Updated: 2026-03-14T23:12:40.778283