PEPTO-BISMOL- bismuth subsalicylate tablet 
The Procter & Gamble Manufacturing Company

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.

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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

477

PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-477
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint Code Pepto;Bismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-477-012 in 1 CELLO PACK; Type 0: Not a Combination Product06/30/2004
2NDC:37000-477-122 in 1 CARTON06/30/2004
26 in 1 CELLO PACK; Type 0: Not a Combination Product
3NDC:37000-477-244 in 1 CARTON06/30/200404/01/2016
36 in 1 CELLO PACK; Type 0: Not a Combination Product
4NDC:37000-477-095 in 1 CARTON06/30/2004
46 in 1 CELLO PACK; Type 0: Not a Combination Product
5NDC:37000-477-108 in 1 CARTON06/30/2004
56 in 1 CELLO PACK; Type 0: Not a Combination Product
6NDC:37000-477-044 in 1 PACKET; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/30/2004
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 5/2021
Document Id: c3154d08-95ea-4697-e053-2995a90a1308
Set id: 0f02f1a4-3ea4-43de-bfdb-b9cb7626f92a
Version: 6
Effective Time: 20210524
 
The Procter & Gamble Manufacturing Company