PEPTO-BISMOL- bismuth subsalicylate 
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 30 mL dose cup)Purposes
Bismuth subsalicylate 525 mgUpset stomach reliever and antidiarrheal
Active ingredient (in each tablet)
Bismuth subsalicylate 262 mgUpset 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

Liquid

  • shake well before use
  • use dose cup or tablespoon (TBSP)
  • adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every ½ to 1 hour as needed
  • do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours

Chewable Tablets

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours

Other information

Pepto-Bismol Liquid

  • each 30 mL dose cup contains:
  • magnesium 25 mg, sodium 8 mg
  • salicylate 261 mg
  • low sodium

Pepto-Bismol Chewable Tablets

  • each tablet contains:
  • calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • very low sodium

Inactive ingredients

Liquid

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate, methylcellulose, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water

Chewable Tablets

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 - Kit Carton

NDC 37000-402-01

Pepto-
Bismol

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5
SYMPTOM
Digestive Relief

TOTAL 32 FL OZ (946 ml) • TWO 16 FL OZ (473 ml) BOTTLES | 48 CHEWABLE TABLETS

Principal Display Panel - Kit Carton
PEPTO-BISMOL 
bismuth subsalicylate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-402
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-402-011 in 1 PACKAGE; Type 0: Not a Combination Product09/12/2011
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE, PLASTIC 946 mL
Part 28 CELLO PACK 48 
Part 1 of 2
PEPTO-BISMOL 
bismuth subsalicylate suspension
Product Information
Item Code (Source)NDC:37000-032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-032-04473 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 finalpart33503/31/1989
Part 2 of 2
PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Item Code (Source)NDC:37000-477
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
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:37000-477-108 in 1 CARTON
16 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33503/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/12/2011
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2019
Document Id: 91be0c59-8c65-c7de-e053-2a95a90ae0d5
Set id: 33baaf04-498d-44f2-9288-02b8f874f914
Version: 5
Effective Time: 20190904
 
The Procter & Gamble Manufacturing Company