Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (262 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium, Unspecified Microcrystalline Cellulose Sodium Salicylate Sorbic Acid Sucrose Water Xanthan Gum

Identifiers & Packaging

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 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever

Section 42229-5

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.

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 50569-3

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

diabetes
gout
arthritis
anticoagulation (thinning the blood)

Section 53414-9

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

Section 55105-1

Active ingredient (per 15 mL)	Purposes
Bismuth subsalicylate 262 mg	Anti-diarrheal Upset stomach reliever

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 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

Inactive I

carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Other Information

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

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

NEW IMPROVED TASTE!

Kaopectate ^®

Bismuth Subsalicylate 262 mg

• 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

11 fl oz (325mL)

Vanilla Flavor

68OVAN11KA0LF

Kaopectate^® Vanilla 11oz

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

680VAN11KA0LB

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

a sodium-restricted diet
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 42229-5 (42229-5)

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.

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 50569-3 (50569-3)

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

diabetes
gout
arthritis
anticoagulation (thinning the blood)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredient (per 15 mL)	Purposes
Bismuth subsalicylate 262 mg	Anti-diarrheal Upset stomach reliever

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 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

Inactive I

carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Other Information

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

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

NEW IMPROVED TASTE!

Kaopectate ^®

Bismuth Subsalicylate 262 mg

• 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

11 fl oz (325mL)

Vanilla Flavor

68OVAN11KA0LF

Kaopectate^® Vanilla 11oz

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

680VAN11KA0LB

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)

a sodium-restricted diet
fever
mucus in the stool

Advanced Ingredient Data

[{"name": "Bismuth Cation", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Carboxymethylcellulose Sodium, Unspecified", "unii": "K679OBS311", "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)

{"34067-9": "Uses relieves: traveler’s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness", "42229-5": "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.", "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", "50569-3": "Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever", "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 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", "Inactive I": "carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum", "Other Information": "each 15 mL dose cup contains: sodium 6 mg and salicylate 135mg store at room temperature 20º-25º C (68º-77º F)", "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": "NEW IMPROVED TASTE! Kaopectate ® Bismuth Subsalicylate 262 mg • 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 11 fl oz (325mL) Vanilla Flavor 68OVAN11KA0LF Kaopectate ® Vanilla 11oz 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 680VAN11KA0LB ", "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": "a sodium-restricted diet 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