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Pepto-Bismol by The Procter & Gamble Manufacturing Company

Medically reviewed on December 19, 2016

Dosage form: kit
Ingredients: BISMUTH SUBSALICYLATE 525mg in 30mL; BISMUTH SUBSALICYLATE 262mg
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-403

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 and 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

  • 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
  • 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

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
  • protect from freezing.
  • avoid excessive heat (over 104°F, 40°C).

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 90 mg, magnesium 8 mg
    • salicylate 99 mg
    • very low sodium

Inactive ingredients

Original 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 37000-403-01

Pepto-
Bismol

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5
SYMPTOM
Digestive Relief

  • heartburn
  • indigestion
  • nausea
  • upset stomach
  • diarrhea

TOTAL 24 FL OZ (708 ml) • TWO 12 FL OZ (354 ml) BOTTLES | 30 InstaCool CHEWABLE TABLETS

PEPTO-BISMOL 
bismuth subsalicylate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-403
Packaging
#Item CodePackage Description
1NDC:37000-403-011 KIT in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE, PLASTIC 708 mL
Part 21 BOTTLE, PLASTIC 30 
Part 1 of 2
PEPTO-BISMOL 
bismuth subsalicylate suspension
Product Information
Item Code (Source)NDC:37000-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION and SALICYLIC ACID) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
WATER 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-032-03354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33503/31/1989
Part 2 of 2
PEPTO-BISMOL   INSTACOOL
bismuth subsalicylate tablet, chewable
Product Information
Item Code (Source)NDC:37000-691
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION and SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
D&C RED NO. 27 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONES 
SACCHARIN SODIUM 
TALC 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-691-301 BOTTLE, PLASTIC in 1 CARTON
130 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
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 finalpart33503/05/2012
Labeler - The Procter & Gamble Manufacturing Company (004238200)

 
The Procter & Gamble Manufacturing Company

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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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