Label: PEPTO BISMOL CHEWS- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 37000-996-24, 37000-996-72
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 20, 2025

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    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

    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 DOCTOR/PHARMACIST

    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, flavor, 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 - 24 CHEWABLE TABLETS

    Pepto Bismol ®

    Bismuth Subsalicylate - Upset Stomach Reliever/Antidiarrheal

    CHEWS

    24 CHEWABLE TABLETS

    996

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL  CHEWS
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-996
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SORBITOL (UNII: 506T60A25R)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    ACACIA (UNII: 5C5403N26O)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCROSE (UNII: C151H8M554)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize18mm
    FlavorWINTERGREENImprint Code PB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-996-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
    2NDC:37000-996-723 in 1 CELLO PACK09/01/2020
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00809/01/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!