Pepto Bismol ®

Pepto Bismol ®
SPL v3
SPL
SPL Set ID 252b143f-eee8-f407-e063-6394a90a0a08
Route
ORAL
Published
Effective Date 2024-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Fd&c Blue No. 2 Aluminum Lake Propylene Glycol Sorbic Acid Sorbitol Icodextrin Acacia Calcium Carbonate Hydrogenated Coconut Oil Carnauba Wax White Wax Anhydrous Citric Acid Starch, Corn Maltodextrin Potassium Hydroxide Corn Syrup Shellac Sodium Benzoate Lecithin, Soybean Titanium Dioxide Sucrose Carminic Acid Water Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: PB Shape: round Color: purple Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02
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
  • fully chew before swallowing
  • adults and children 12 years and over:
  •      2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
  •      2 chewable tablets every ½ hour to 1 hour 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

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 chewable tablet contains:
  • calcium 50 mg • salicylate 117 mg
  • low sodium
  • Store at no greater than 25°C. Avoid excessive heat (over 40°C.)
Inactive Ingredients

acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

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

Principal Display Panel 70 Chewable Tablets

Pepto Bismol

Bismuth Subsalicylate -

Upset Stomach Reliever/ Antidiarrheal

CHEWS

BERRY MINT FLAVORED

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

70 CHEWABLE TABLETS

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
  • fully chew before swallowing
  • adults and children 12 years and over:
  •      2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
  •      2 chewable tablets every ½ hour to 1 hour 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

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:)

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 (Other information)
  • each chewable tablet contains:
  • calcium 50 mg • salicylate 117 mg
  • low sodium
  • Store at no greater than 25°C. Avoid excessive heat (over 40°C.)
Inactive Ingredients (Inactive ingredients)

acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

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.

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

Principal Display Panel 70 Chewable Tablets (PRINCIPAL DISPLAY PANEL - 70 Chewable Tablets)

Pepto Bismol

Bismuth Subsalicylate -

Upset Stomach Reliever/ Antidiarrheal

CHEWS

BERRY MINT FLAVORED

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

70 CHEWABLE TABLETS

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:11.813446 · Updated: 2026-03-14T23:10:24.980101