Pepto Bismol

Pepto Bismol
SPL v6
SPL
SPL Set ID d04e42bf-2748-f12b-e053-2a95a90a35e5
Route
ORAL
Published
Effective Date 2021-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Mannitol Talc Calcium Carbonate Magnesium Stearate Povidone, Unspecified D&c Red No. 27 Aluminum Lake Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Imprint: Pepto;Bismol Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Completed Since 2017-02-06 Until 2025-10-13

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves

• travelers' diarrhea

• diarrhea

• upset stomach due to overindulgence in food and drink, including:

• heartburn

• indigestion

• nausea

• gas

• belching

• fullness

Section 42229-5

PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:

Convenience Valet® Glendale Heights, IL 60139 1-800-351-2000 (8:30 AM - 5:00 PM CST)

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 51945-4

Pepto Bismol

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

4 CHEWABLE TABLETS



Section 53414-9

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

Directions
  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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 99 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 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
Ask A Doctor Before Use If
  • fever
  • mucus in the stool
Stop Use and Ask A Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

Active Ingredient(in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product a temporary, but harmless, darkening of the stool and/or

tongue may occur


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)

PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:

Convenience Valet® Glendale Heights, IL 60139 1-800-351-2000 (8:30 AM - 5:00 PM CST)

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 51945-4 (51945-4)

Pepto Bismol

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

4 CHEWABLE TABLETS



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 and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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)

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 99 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • fever
  • mucus in the stool
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse
  • 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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product a temporary, but harmless, darkening of the stool and/or

tongue may occur


Advanced Ingredient Data


Raw Label Data

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