Pepto Bismol ®

SPL v9

SPL

SPL Set ID 66d9d631-ba73-3ce4-e053-2a91aa0a1cc4

Route

ORAL

Published

Effective Date 2023-08-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (262 mg)

Inactive Ingredients

D&c Red No. 27 Aluminum Lake Calcium Carbonate Magnesium Stearate Mannitol Cellulose, Microcrystalline Polysorbate 80 Silicon Dioxide Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: PeptoBismol Shape: oval 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 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 50566-9

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

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

• swallow with water, do not chew

• adults and children 12 years and over:

2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 caplets) 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

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 caplet contains: calcium 27 mg
salicylate 99 mg
low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 262 mg

Principal Display Panel 24 Caplet Carton

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

24 CAPLETS

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 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 50566-9 (50566-9)

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

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

• swallow with water, do not chew

• adults and children 12 years and over:

2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

Questions?

1-800-717-3786

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 caplet contains: calcium 27 mg
salicylate 99 mg
low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 262 mg

Principal Display Panel 24 Caplet Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Carton)

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

24 CAPLETS

Advanced Ingredient Data

[{"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "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": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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", "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.", "50566-9": "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", "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": "• swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 caplets) 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", "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 caplet contains: calcium 27 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)", "Inactive ingredients": "calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate", "Active ingredient (in each caplet)": "Bismuth subsalicylate 262 mg", "PRINCIPAL DISPLAY PANEL - 24 Caplet Carton": "Pepto Bismol ® Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 24 CAPLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.969676 · Updated: 2026-03-14T23:12:59.392851