Pepto Bismol ®

SPL v1

SPL

SPL Set ID 30b6adb2-48da-875b-e063-6394a90a593b

Route

ORAL

Published

Effective Date 2025-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (262 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-01

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

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

• fully chew or dissolve in mouth before swallowing

• adults and children 12 years and over:

• 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea

• 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 chewable 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

Other Information

each chewable tablet contains:
calcium 140 mg, magnesium 10 mg
salicylate 101 mg
low sodium
Store at no greater than 77°F. Avoid excessive heat (over 104°F.)

Inactive Ingredients

adipic acid, calcium carbonate, D&C Red No 27 Aluminum Lake, FD&C Red No 40 Aluminum Lake, Flavors, magnesium stearate, mannitol, povidone, saccharin sodium, talc, water

Do Not Use If You Have

an ulcer
a bleeding problem
bloody or black stool

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Active Ingredient (in Each Chewable Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Principal Display Panel 12 Chewable Tablets Carton

Pepto

Bismol ^®

CHEWABLES

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal

TRAVEL SIZE

FAST 5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 CHEWABLE TABLETS

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

Purpose

Upset stomach reliever and antidiarrheal

Warnings

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

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

Directions

• fully chew or dissolve in mouth before swallowing

• adults and children 12 years and over:

• 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea

• 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 chewable 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

Other Information (Other information)

each chewable tablet contains:
calcium 140 mg, magnesium 10 mg
salicylate 101 mg
low sodium
Store at no greater than 77°F. Avoid excessive heat (over 104°F.)

Inactive Ingredients (Inactive ingredients)

adipic acid, calcium carbonate, D&C Red No 27 Aluminum Lake, FD&C Red No 40 Aluminum Lake, Flavors, magnesium stearate, mannitol, povidone, saccharin sodium, talc, water

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

an ulcer
a bleeding problem
bloody or black stool

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

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.)

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 Chewable Tablet) (Active ingredient (in each chewable tablet))

Bismuth subsalicylate 262 mg

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

Principal Display Panel 12 Chewable Tablets Carton (PRINCIPAL DISPLAY PANEL - 12 Chewable Tablets Carton)

Pepto

Bismol ^®

CHEWABLES

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal

TRAVEL SIZE

FAST 5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 CHEWABLE TABLETS

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": "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": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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", "Purpose": "Upset stomach reliever and antidiarrheal", "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": "• fully chew or dissolve in mouth before swallowing • adults and children 12 years and over: • 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea • 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 chewable 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", "Other information": "each chewable tablet contains: calcium 140 mg, magnesium 10 mg salicylate 101 mg low sodium Store at no greater than 77°F. Avoid excessive heat (over 104°F.)", "Inactive ingredients": "adipic acid, calcium carbonate, D&C Red No 27 Aluminum Lake, FD&C Red No 40 Aluminum Lake, Flavors, magnesium stearate, mannitol, povidone, saccharin sodium, talc, water", "Do not use if you have": "an ulcer a bleeding problem bloody or black stool", "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", "If pregnant or breast feeding,": "ask a health professional before use.", "Ask a doctor before use if you have": "fever mucus in the stool", "Active ingredient (in each chewable tablet)": "Bismuth subsalicylate 262 mg", "Ask a doctor or pharmacist before use if you are": "taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis", "PRINCIPAL DISPLAY PANEL - 12 Chewable Tablets Carton": "Pepto Bismol ® CHEWABLES Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal TRAVEL SIZE FAST 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 12 CHEWABLE TABLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:49.515987 · Updated: 2026-03-14T23:08:10.789867