Pepto-bismol™

SPL v1

SPL

SPL Set ID 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3

Route

ORAL

Published

Effective Date 2022-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (262 mg)

Inactive Ingredients

Calcium Carbonate Magnesium Stearate Mannitol Povidone, Unspecified D&c Red No. 27 Aluminum Lake Saccharin Sodium Talc

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH FINAL 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 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 53414-9

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

Directions

chew or dissolve in mouth
adults & children 12 years & over:

2 tablets every 1/2 to 1 hour as needed
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

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 tablet contains:
- calcium 140 mg, magnesium 9 mg
- salicylate 101 mg
- very low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

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

Do Not Use If You Have

an ulcer
a bleeding problem
bloody or black stool

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

Principal Display Panel 4 Tablet Pouch Blister Pack

Pepto-

Bismol_™

BISMUTH SUBSALICYLATE

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5

SYMPTOM

Digestive Relief

heartburn
indigestion
nausea
upset stomach
diarrhea

4 Chewable Tablets

Multi-Pack

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 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 53414-9 (53414-9)

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

Purpose

Upset stomach reliever and Antidiarrheal

Directions

chew or dissolve in mouth
adults & children 12 years & over:

2 tablets every 1/2 to 1 hour as needed
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

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 tablet contains:
- calcium 140 mg, magnesium 9 mg
- salicylate 101 mg
- very low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients (Inactive ingredients)

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

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

an ulcer
a bleeding problem
bloody or black stool

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

Principal Display Panel 4 Tablet Pouch Blister Pack (PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Blister Pack)

Pepto-

Bismol_™

BISMUTH SUBSALICYLATE

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5

SYMPTOM

Digestive Relief

heartburn
indigestion
nausea
upset stomach
diarrhea

4 Chewable Tablets

Multi-Pack

Advanced Ingredient Data

[{"name": "salicylic acid", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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, unspecified", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": ""}]

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.", "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Upset stomach reliever and Antidiarrheal", "Directions": "chew or dissolve in mouth adults & children 12 years & over: 2 tablets every 1/2 to 1 hour as needed 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", "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 tablet contains: calcium 140 mg, magnesium 9 mg salicylate 101 mg very low sodium avoid excessive heat (over 104°F or 40°C)", "Inactive ingredients": "calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc", "Do not use if you have": "an ulcer a bleeding problem bloody or black stool", "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", "PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Blister Pack": "Pepto- Bismol ™ BISMUTH SUBSALICYLATE UPSET STOMACH RELIEVER/ANTIDIARRHEAL 5 SYMPTOM Digestive Relief heartburn indigestion nausea upset stomach diarrhea 4 Chewable Tablets Multi-Pack"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:11.418330 · Updated: 2026-03-14T23:00:33.718954