Pepto Bismol ®

SPL v5

SPL

SPL Set ID 06fc9cc7-eddd-62be-e063-6294a90aa175

Route

ORAL

Published

Effective Date 2018-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 mg)

Inactive Ingredients

D&c Red No. 27 Aluminum Lake Saccharin Sodium Talc Calcium Carbonate Magnesium Stearate Mannitol Povidone Aluminum Oxide Adipic Acid Fd&c Red No. 40 Aluminum Lake

Identifiers & Packaging

Pill Appearance

Imprint: Pepto;Bismol Shape: round Color: pink Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-06-30

Description

Drug Facts

Purpose

Upset stomach reliever and antidiarrheal

Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Drug Facts

Uses

relieves

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

Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

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. Do not take if you are

• allergic to salicylates (including aspirin) • taking other salicylate products

Directions

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
do not exceed 8 doses (16 tablets) 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

Questions?

1-800-717-3786

Do Not Use If

you have

an ulcer
a bleeding problem
bloody or black stool

Other Information

each tablet contains:calcium 140 mg, magnesium 9 mg
salicylate 99 mg
low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

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 or last more than 2 days
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Active Ingredient (in Each Tablet) Purpose

Upset stomach reliever and antidiarrheal

Principal Display Panel 30 Tablet Carton

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal

CHEWABLES

CHERRY

5 SYMPTOM

RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

30 CHEWABLE TABLETS

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Structured Label Content

Uses

relieves

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

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Warnings

Allergy alert: Contains salicylate. Do not take if you are

• allergic to salicylates (including aspirin) • taking other salicylate products

Directions

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
do not exceed 8 doses (16 tablets) 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

Questions?

1-800-717-3786

Do Not Use If (Do not use if)

you have

an ulcer
a bleeding problem
bloody or black stool

Other Information (Other information)

each tablet contains:calcium 140 mg, magnesium 9 mg
salicylate 99 mg
low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients (Inactive ingredients)

adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

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 or last more than 2 days
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

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

fever
mucus in the stool

Active Ingredient (in Each Tablet) Purpose (Active ingredient (in each tablet) Purpose)

Upset stomach reliever and antidiarrheal

Principal Display Panel 30 Tablet Carton (PRINCIPAL DISPLAY PANEL - 30 Tablet Carton)

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal

CHEWABLES

CHERRY

5 SYMPTOM

RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

30 CHEWABLE TABLETS

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

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

[{"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "525", "strengthDenominator": "2", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40 ALUMINUM LAKE", "unii": "6T47AS764T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "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. Do not take if you are • allergic to salicylates (including aspirin) • taking other salicylate products", "Directions": "chew or dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) 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", "Questions?": "1-800-717-3786", "Do not use if": "you have an ulcer a bleeding problem bloody or black stool", "Other information": "each tablet contains: calcium 140 mg, magnesium 9 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)", "Inactive ingredients": "adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc", "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 or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days", "Active ingredient (in each tablet)": "Bismuth subsalicylate 262 mg", "Ask a doctor before use if you have": "fever mucus in the stool", "Active ingredient (in each tablet) Purpose": "Upset stomach reliever and antidiarrheal", "PRINCIPAL DISPLAY PANEL - 30 Tablet Carton": "Pepto Bismol ® Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal CHEWABLES CHERRY 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 30 CHEWABLE TABLETS", "Ask a doctor or pharmacist before use if you are": "taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.547309 · Updated: 2026-03-14T23:10:21.394156