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Pepto-Bismol by Procter & Gamble Manufacturing Company

Dosage form: tablet
Ingredients: Bismuth subsalicylate 262mg
Labeler: Procter & Gamble Manufacturing Company
NDC Code: 37000-476

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 caplet)

Bismuth subsalicylate 262 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: 2 caplets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 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 27 mg
  • sodium 3 mg
  • salicylate 99 mg
  • low sodium
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, red 27 aluminum lake, silicon dioxide, sodium starch glycolate

Questions?

1-800-717-3786

www.pepto-bismol.com

Made in Mexico by Procter & Gamble

Dist. by Procter & Gamble, Cincinnati OH 45202. U.S.

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

Pepto•
BISMOL

5 SYMPTOM RELIEF

Nausea • Heartburn • Indigestion
Upset Stomach • Diarrhea

NDC 37000-476-02

BISMUTH
SUBSALICYLATE
UPSET STOMACH
RELIEVER/
ANTIDIARRHEAL

24
CAPLETS

PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-476
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth subsalicylate (Bismuth subsalicylate) Bismuth subsalicylate262 mg
Inactive Ingredients
Ingredient NameStrength
calcium carbonate 
magnesium stearate 
mannitol 
cellulose, microcrystalline 
polysorbate 80 
povidone 
D&C RED NO. 27 
aluminum oxide 
silicon dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (Caplet) Size16mm
FlavorImprint CodePeptoBismol
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-476-011 BLISTER PACK (BLISTER PACK) in 1 POUCH
12 TABLET (TABLET) in 1 BLISTER PACK
2NDC:37000-476-021 BOTTLE (BOTTLE) in 1 CARTON
224 TABLET (TABLET) in 1 BOTTLE
3NDC:37000-476-031 BOTTLE (BOTTLE) in 1 CARTON
330 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/30/2004
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 05/2011
 
Procter & Gamble Manufacturing Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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