Pepto Bismol ®

SPL v11

SPL

SPL Set ID 84ffa6d6-03e1-59e8-e053-2a91aa0afd6e

Route

ORAL

Published

Effective Date 2023-06-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (262 mg)

Inactive Ingredients

Polysorbate 20 Sorbitol Titanium Dioxide Gelatin Povidone D&c Red No. 33 Polyethylene Glycol 400 Glycerin

Identifiers & Packaging

Pill Appearance

Imprint: PB Shape: capsule Color: pink Size: 14 mm Score: 1

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

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.

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea

• 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 16 LiquiCaps 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

Allergy Alert:

Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

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 LiquiCap contains:

• salicylate 199 mg

• low sodium

• do not exceed 25°C

Inactive Ingredients

D&C Red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

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 Liquicap)

Bismuth subsalicylate 262 mg

Principal Display Panel 48 Liquicap Carton

FAST & SOOTHING RELIEF

Pepto

Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LIQUICAPS™

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.

Purpose

Upset stomach reliever and antidiarrheal

Directions

Questions?

1-800-717-3786

Do Not Use If (Do not use if)

you have

an ulcer
a bleeding problem
bloody or black stool

Allergy Alert: (Allergy alert:)

Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

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

Other Information (Other information)

• each LiquiCap contains:

• salicylate 199 mg

• low sodium

• do not exceed 25°C

Inactive Ingredients (Inactive ingredients)

D&C Red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

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.

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 Liquicap) (Active ingredient (in each LiquiCap))

Bismuth subsalicylate 262 mg

Principal Display Panel 48 Liquicap Carton (PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton)

FAST & SOOTHING RELIEF

Pepto

Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LIQUICAPS™

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": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "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", "50565-1": "Keep out of reach of children.", "Purpose": "Upset stomach reliever and antidiarrheal", "Directions": "• swallow with water, do not chew • adults and children 12 years and over: • 2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea • 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 16 LiquiCaps 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", "Allergy alert:": "Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products", "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 LiquiCap contains: • salicylate 199 mg • low sodium • do not exceed 25°C", "Inactive ingredients": "D&C Red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide", "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 LiquiCap)": "Bismuth subsalicylate 262 mg", "PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton": "FAST & SOOTHING RELIEF Pepto Bismol® Bismuth Subsalicylate Upset Stomach Reliever/Antidiarrheal LIQUICAPS 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 48 LIQUICAPS™", "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: 2026-02-15T12:07:08.607539 · Updated: 2026-03-14T23:10:23.192014