Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (262 mg)

Inactive Ingredients

Croscarmellose Sodium Crospovidone Hydrated Silica Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Mineral Oil Povidone, Unspecified Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: K Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-10-01

Medication Information

Indications and Usage

Uses relieves:

traveler’s diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness

Description

Active ingredient (per caplet) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal, Upset stomach reliever

Section 50565-1

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

Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

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

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredient (per caplet)	Purposes
Bismuth subsalicylate 262 mg	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

adults and children 12 years of age and older: 2 caplets (1 dose)
swallow caplets with water; do not chew
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

Each caplet contains very low sodium
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

croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

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

FAST & EFFECTIVE RELIEF

Kaopectate ^®

Bismuth Subsalicylate

• Anti-Diarrheal • Upset Stomach Reliver

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

CLINICALLY PROVEN MEDICINE

28 Coated Caplets

LOT

EXP

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

14711-07-20_K0720

Kaopectate ^®

Bismuth Subsalicylate

Anti-Diarrheal
Upset Stomach Reliever

Diarrhea & Upset Stomach

28 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

14712-07-20_K0720

Kaopectate ^®

Bismuth Subsalicylate

Anti-Diarrheal
Upset Stomach Reliever

Diarrhea & Upset Stomach

84 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

K0625

LOT:

EXP:

R54039

Kramer Laboratories, Inc. Bridgewater, NJ 08807

1-800-824-4894

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

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Structured Label Content

Indications and Usage (34067-9)

Uses relieves:

traveler’s diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

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

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredient (per caplet)	Purposes
Bismuth subsalicylate 262 mg	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

adults and children 12 years of age and older: 2 caplets (1 dose)
swallow caplets with water; do not chew
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 (Other information)

Each caplet contains very low sodium
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 ingredients)

croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

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

FAST & EFFECTIVE RELIEF

Kaopectate ^®

Bismuth Subsalicylate

• Anti-Diarrheal • Upset Stomach Reliver

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

CLINICALLY PROVEN MEDICINE

28 Coated Caplets

LOT

EXP

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

14711-07-20_K0720

Kaopectate ^®

Bismuth Subsalicylate

Anti-Diarrheal
Upset Stomach Reliever

Diarrhea & Upset Stomach

28 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

14712-07-20_K0720

Kaopectate ^®

Bismuth Subsalicylate

Anti-Diarrheal
Upset Stomach Reliever

Diarrhea & Upset Stomach

84 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

K0625

LOT:

EXP:

R54039

Kramer Laboratories, Inc. Bridgewater, NJ 08807

1-800-824-4894

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

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

fever
mucus in the stool

Advanced Ingredient Data

[{"name": "Bismuth Cation", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Croscarmellose Sodium", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Crospovidone", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrated Silica", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hypromellose, Unspecified", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Magnesium Stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Microcrystalline Cellulose", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Mineral Oil", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Povidone, Unspecified", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Lauryl Sulfate", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Stearic Acid", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Talc", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Titanium Dioxide", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Triacetin", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves: traveler’s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur", "50568-5": "Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredient (per caplet) Purposes Bismuth subsalicylate 262 mg 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": "adults and children 12 years of age and older: 2 caplets (1 dose) swallow caplets with water; do not chew 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": "Each caplet contains very low sodium 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": "croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin ", "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": "FAST & EFFECTIVE RELIEF Kaopectate ® Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliver 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 CLINICALLY PROVEN MEDICINE 28 Coated Caplets LOT EXP Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken. Kramer Laboratories, Inc. Bridgewater, NJ 08807 1-800-824-4894 14711-07-20_K0720 Kaopectate ® Bismuth Subsalicylate Anti-Diarrheal Upset Stomach Reliever Diarrhea & Upset Stomach 28 Coated Caplets Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken. KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION Kramer Laboratories, Inc. Bridgewater, NJ 08807 1-800-824-4894 14712-07-20_K0720 Kaopectate ® Bismuth Subsalicylate Anti-Diarrheal Upset Stomach Reliever Diarrhea & Upset Stomach 84 Coated Caplets Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken. K0625 LOT: EXP: R54039 Kramer Laboratories, Inc. Bridgewater, NJ 08807 1-800-824-4894", "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", "Ask a doctor before use if you have": "fever mucus in the stool"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information