PEPTO-BISMOL ULTRA- bismuth subsalicylate suspension 
The Procter & Gamble Manufacturing Company

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Pepto
Bismol ®
ULTRA

Drug Facts

Active ingredient (in each 15 mL dose)

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

  • 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 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.

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

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

Questions?

1-800-717-3786

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

P epto

Bismol®ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal

2x CONCENTRATED FORMULA*

5 SYMPTOMRELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

8 FL OZ (236 mL)

440

PEPTO-BISMOL  ULTRA
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-440-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
2NDC:37000-440-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
3NDC:37000-440-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
4NDC:37000-440-363 in 1 CELLO PACK03/01/2022
4354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00803/01/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2023
Document Id: 070d0892-79d8-7e41-e063-6394a90a9cc0
Set id: 673893bd-f8e9-23b0-e053-2a91aa0aa1d4
Version: 8
Effective Time: 20231006
 
The Procter & Gamble Manufacturing Company