PEPTO-BISMOL ULTRA- bismuth subsalicylate tablet 
Procter & Gamble Manufactura, S. de R.L. de C.V.

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Pepto ® BISMOL™ ULTRA

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking any drug for

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

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

Other information

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

Bismol® ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal

2x CONCENTRATED FORMULA*

5 SYMPTOM RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CAPLETS

478

PEPTO-BISMOL  ULTRA
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-478
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
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:58933-478-241 in 1 CARTON02/01/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58933-478-121 in 1 CARTON02/01/2018
212 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00802/01/2018
Labeler - Procter & Gamble Manufactura, S. de R.L. de C.V. (812807550)

Revised: 10/2023
Document Id: 07100573-509b-53cf-e063-6394a90a92db
Set id: 63283ebc-cff8-07d4-e053-2a91aa0a9de0
Version: 8
Effective Time: 20231006
 
Procter & Gamble Manufactura, S. de R.L. de C.V.