Pepto ®

Pepto ®
SPL v10
SPL
SPL Set ID 8517edac-fda7-7a49-e053-2a91aa0a24cd
Route
ORAL
Published
Effective Date 2023-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Benzoic Acid Magnesium Aluminum Silicate D&c Red No. 22 D&c Red No. 28 Sucralose Salicylic Acid Sodium Salicylate Sorbic Acid Water Gellan Gum (high Acyl) Methylcellulose, Unspecified

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-03-01 Until 2026-06-30

Description

Drug Facts

Purpose

Antidiarrheal


Medication Information

Purpose

Antidiarrheal

Description

Drug Facts

Uses

relieves

  • travelers' diarrhea
  • diarrhea
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
  • shake well before use
  • adults and children 12 years and over:
  • 10 mL (1 dose) every ½ hour to 1 hour or 20 mL (2 doses) every hour as needed for diarrhea/travelers’ diarrhea
  • do not exceed 8 doses (80 mL) 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 10 mL dose contains:salicylate 212 mg
    • low sodium
    • store at no greater than 30°C
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

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
  • 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 10 Ml Dose)

Bismuth subsalicylate 525 mg

Principal Display Panel 118 Ml Bottle Label

*vs. Original Pepto Bismol®

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

CHERRY

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

4 FL OZ

(118 mL)

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
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

Antidiarrheal

Directions
  • shake well before use
  • adults and children 12 years and over:
  • 10 mL (1 dose) every ½ hour to 1 hour or 20 mL (2 doses) every hour as needed for diarrhea/travelers’ diarrhea
  • do not exceed 8 doses (80 mL) 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 (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:)

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 10 mL dose contains:salicylate 212 mg
    • low sodium
    • store at no greater than 30°C
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients (Inactive ingredients)

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

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
  • 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 10 Ml Dose) (Active ingredient (in each 10 mL dose))

Bismuth subsalicylate 525 mg

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

*vs. Original Pepto Bismol®

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

CHERRY

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

4 FL OZ

(118 mL)

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)