Pepto Bismol ®

SPL v16

SPL

SPL Set ID 67006e82-870d-8d63-e053-2991aa0a02d1

Route

ORAL

Published

Effective Date 2025-07-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 mg)

Inactive Ingredients

Gellan Gum (high Acyl) Magnesium Aluminum Silicate Benzoic Acid D&c Red No. 22 D&c Red No. 28 Sucralose Salicylic Acid Sodium Salicylate Sorbic Acid Water Methylcellulose, Unspecified

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Drug Facts

Purpose

Upset stomach reliever and antidiarrheal

Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Drug Facts

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

Drug Facts

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 50569-3

Ask a doctor before use if you have

fever
mucus in the stool

Section 50570-1

Do not use if you have

an ulcer
a bleeding problem
bloody or black stool

Section 53414-9

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

Directions

shake well before use
only use dose cup provided
adults and children 12 years and over:
30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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

Questions?

1-800-717-3786

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.

Other Information

each 30 mL dose contains: magnesium 3 mg, sodium 4 mg
- salicylate 261 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Inactive Ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

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 30 Ml Dose)

Bismuth subsalicylate 525 mg

Principal Display Panel 354 Ml Bottle Label

Pepto

Bismol ^®

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

5 SYMPTOM

RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 FL OZ (354 mL)

Allergy Alert: Contains Salicylate. Do Not Take If You Are

allergic to salicylates (including aspirin)
taking other salicylate products

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

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

Ask a doctor before use if you have

fever
mucus in the stool

Section 50570-1 (50570-1)

Do not use if you have

an ulcer
a bleeding problem
bloody or black stool

Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever and antidiarrheal

Directions

shake well before use
only use dose cup provided
adults and children 12 years and over:
30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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

Questions?

1-800-717-3786

Reye's Syndrome: (Reye's syndrome:)

Other Information (Other information)

each 30 mL dose contains: magnesium 3 mg, sodium 4 mg
- salicylate 261 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Inactive Ingredients (Inactive ingredients)

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

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 30 Ml Dose) (Active ingredient (in each 30 mL dose))

Bismuth subsalicylate 525 mg

Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label)

Pepto

Bismol ^®

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

5 SYMPTOM

RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 FL OZ (354 mL)

Allergy Alert: Contains Salicylate. Do Not Take If You Are (Allergy alert: Contains salicylate. Do not take if you are)

allergic to salicylates (including aspirin)
taking other salicylate products

Advanced Ingredient Data

[{"name": "GELLAN GUM (HIGH ACYL)", "unii": "W1L7G7ROMD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 22", "unii": "1678RKX8RT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLCELLULOSE, UNSPECIFIED", "unii": "Z944H5SN0H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "525", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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", "42229-5": "Drug Facts", "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", "50569-3": "Ask a doctor before use if you have fever mucus in the stool", "50570-1": "Do not use if you have an ulcer a bleeding problem bloody or black stool", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Upset stomach reliever and antidiarrheal", "Directions": "shake well before use only use dose cup provided adults and children 12 years and over: 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 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", "Questions?": "1-800-717-3786", "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.", "Other information": "each 30 mL dose contains: magnesium 3 mg, sodium 4 mg salicylate 261 mg low sodium protect from freezing avoid excessive heat (over 104°F or 40°C) TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.", "Inactive ingredients": "benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water", "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 30 mL dose)": "Bismuth subsalicylate 525 mg", "PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label": "Pepto Bismol ® Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 12 FL OZ (354 mL)", "Allergy alert: Contains salicylate. Do not take if you are": "allergic to salicylates (including aspirin) taking other salicylate products"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.590007 · Updated: 2026-03-14T23:12:56.390264