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Pepto-Bismol by The Procter & Gamble Manufacturing Company

Dosage form: tablet
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-477

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™

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

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
  • chew or dissolve in mouth
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

1-800-717-3786

Dist. by Procter & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 12 Chewable Tablet Cello Pack Carton

P epto
Bismol®

Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal


CHEWABLES


5 SYMPTOM

RELIEF


NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CHEWABLE TABLETS

PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-477
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
D&C RED NO. 27 ALUMINUM LAKE 
SACCHARIN SODIUM 
TALC 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint CodePepto;Bismol
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-477-012 TABLET in 1 CELLO PACK
2NDC:37000-477-122 CELLO PACK in 1 CARTON
26 TABLET in 1 CELLO PACK
3NDC:37000-477-244 CELLO PACK in 1 CARTON
36 TABLET in 1 CELLO PACK
4NDC:37000-477-095 CELLO PACK in 1 CARTON
46 TABLET in 1 CELLO PACK
5NDC:37000-477-108 CELLO PACK in 1 CARTON
56 TABLET in 1 CELLO PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/30/2004
Labeler - The Procter & Gamble Manufacturing Company (004238200)

 
The Procter & Gamble Manufacturing Company

Medically reviewed on Mar 7, 2018

See Also

Further information

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

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