Label: PEPTO-BISMOL- bismuth subsalicylate kit

  • NDC Code(s): 37000-032-04, 37000-402-01, 37000-477-10
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 4, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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 104ºF, 40ºC)

    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

  • SPL UNCLASSIFIED SECTION

    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

    • heartburn
    • indigestion
    • nausea
    • upset stomach
    • diarrhea

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

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    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)