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Pepto-Bismol ULTRA by The Procter & Gamble Manufacturing Company

Medically reviewed on January 19, 2018

Dosage form: tablet
Ingredients: BISMUTH SUBSALICYLATE 525mg
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-478

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pepto•
BISMOL™ ULTRA

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

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
  • swallow with water, do not chew
  • adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (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

www.pepto-bismol.com

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

NEW

Pepto•
Bismol
® ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal

2x STRENGTH

per caplet*

5 SYMPTOM RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CAPLETS

PEPTO-BISMOL  ULTRA
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-478
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE525 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POVIDONE 
D&C RED NO. 27 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
SILICON DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Caplet) Size18mm
FlavorImprint CodePepto
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-478-241 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:37000-478-121 BOTTLE in 1 CARTON
212 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/01/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

 
The Procter & Gamble Manufacturing Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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