Label: PEPTO BISMOL- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 29485-1531-4, 29485-6754-6
  • Packager: Lil' Drug Store Products, Inc.
  • 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 July 19, 2023

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  • Drug Facts

  • Active Ingredient(in each tablet)

    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
    • 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 1/2 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 99 mg
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • Inactive Ingredients

    adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:

    Convenience Valet® Glendale Heights, IL 60139 1-800-351-2000 (8:30 AM - 5:00 PM CST)

  • PRINCIPAL DISPLAY PANEL

    Pepto Bismol
    Bismuth Subsalicylate
    Upset Stomach Reliever/Antidiarrheal

    CHEWABLES

    5 SYMPTOM RELIEF

    NAUSEA

    HEARTBURN

    INDIGESTION

    UPSET STOMACH

    DIARRHEA

    4 CHEWABLE TABLETS


    PEPTO 4CT

  • PRINCIPAL DISPLAY PANEL

    Pepto Bismol
    Bismuth Subsalicylate
    Upset Stomach Reliever/Antidiarrheal

    CHEWABLES

    5 SYMPTOM RELIEF

    NAUSEA

    HEARTBURN

    INDIGESTION

    UPSET STOMACH

    DIARRHEA

    6 CHEWABLE TABLETS

    Pepto 6ct

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1531
    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
    MANNITOL (UNII: 3OWL53L36A)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code Pepto;Bismol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-1531-42 in 1 BLISTER PACK04/30/200211/03/2025
    12 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00104/30/200211/03/2025
    PEPTO BISMOL 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6754
    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
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code Pepto;Bismol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-6754-63 in 1 BLISTER PACK02/06/201710/13/2025
    12 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00102/06/201710/13/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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