Label: PEPTO BISMOL- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 84126-321-70
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable 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 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

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • fully chew before swallowing
    • adults and children 12 years and over:
    •      2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
    •      2 chewable tablets every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (16 chewable 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 chewable tablet contains:
    • calcium 50 mg • salicylate 117 mg
    • low sodium
    • Store at no greater than 25°C. Avoid excessive heat (over 40°C.)
  • Inactive ingredients

    acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 70 Chewable Tablets

    Pepto Bismol

    Bismuth Subsalicylate -

    Upset Stomach Reliever/ Antidiarrheal

    CHEWS

    BERRY MINT FLAVORED

    NAUSEA
    HEARTBURN
    INDIGESTION
    UPSET STOMACH
    DIARRHEA

    70 CHEWABLE TABLETS

    321

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-321
    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
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCROSE (UNII: C151H8M554)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize18mm
    FlavorBERRY, MINTImprint Code PB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-321-7070 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00812/02/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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