Label: PEPTO-BISMOL DIARRHEA- bismuth subsalicylate tablet

  • NDC Code(s): 58933-391-12
  • Packager: Procter & Gamble Manufacturing México, S. de R.L. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Bismuth subsalicylate 525 mg

  • Purpose

    Antidiarrheal

  • Uses

    relieves

    • travelers' diarrhea
    • diarrhea
  • 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

    • swallow with water, do not chew
    • adults and children 12 years and over: 
    • 1 caplet every ½ hour or 2 caplets every hour as needed
    • do not exceed 8 caplets 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 caplet contains: calcium 54 mg
    • salicylate 199 mg
    • very low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

  • SPL UNCLASSIFIED SECTION

    MADE IN MEXICO
    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

    Pepto ®
    Diarrhea

    Bismuth Subsalicylate

    Antidiarrheal

    2x CONCENTRATED FORMULA*

    COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

    12 CAPLETS

    391

  • INGREDIENTS AND APPEARANCE
    PEPTO-BISMOL  DIARRHEA
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-391
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Caplet) Size18mm
    FlavorImprint Code Pepto
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58933-391-121 in 1 CARTON03/01/201906/30/2026
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00803/01/201806/30/2026
    Labeler - Procter & Gamble Manufacturing México, S. de R.L. de C.V. (812807550)
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