PEPTO-BISMOL DIARRHEA- bismuth subsalicylate tablet 
The Procter & Gamble Manufacturing Company

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Pepto Bismol ® Diarrhea Caplets

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 525 mg

Purpose

Antidiarrheal

Uses

relieves

  • travelers' diarrhea
  • diarrhea

Warnings

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.

Allergy alert:

Contains salicylate .

Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • swallow with water, do not chew
  • adults and children 12 years and over: 
  • 1 caplet every ½ hour or 2 caplets every hour as needed
  • do not exceed 8 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

Other information

  • each caplet contains: calcium 54 mg
  • salicylate 199 mg
  • very 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

Questions?

1-800-717-3786

TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

Pepto®
Diarrhea

Bismuth Subsalicylate

Antidiarrheal

2x CONCENTRATED FORMULA*

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

12 CAPLET391S

PEPTO-BISMOL  DIARRHEA
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-391
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Caplet) Size18mm
FlavorImprint Code Pepto
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-391-121 in 1 CARTON03/01/201903/01/2019
112 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00803/01/201803/01/2019
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2023
Document Id: 0ac22f64-ff8f-4608-e063-6294a90a1137
Set id: 84ef11ab-2707-4d42-e053-2991aa0a96bd
Version: 7
Effective Time: 20231122
 
The Procter & Gamble Manufacturing Company