Label: PEPTO BISMOL CHEWABLES- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 58933-011-02, 58933-011-04, 58933-011-12, 58933-011-30, view more
    58933-011-48, 58933-011-90
  • Packager: Procter & Gamble Manufactura S de RL de CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    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 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

    • 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 1/2 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 101 mg
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    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

    TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

  • SPL UNCLASSIFIED SECTION

    MADE IN MEXICO

    DIST. BY PROCTER & GAMBLE

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 12 Chewable Tablet Carton

    Pepto
    Bismol®

    Bismuth Subsalicylate

    Upset Stomach Reliever/ Antidiarrheal


    CHEWABLES


    5 SYMPTOM

    RELIEF


    NAUSEA
    HEARTBURN
    INDIGESTION
    UPSET STOMACH
    DIARRHEA

    12 CHEWABLE TABLETS

    477

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL  CHEWABLES
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-011
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    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:58933-011-022 in 1 PACKET; Type 0: Not a Combination Product06/30/2004
    2NDC:58933-011-122 in 1 CARTON06/30/2004
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58933-011-305 in 1 CARTON06/30/2004
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:58933-011-488 in 1 CARTON06/30/2004
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:58933-011-044 in 1 PACKET; Type 0: Not a Combination Product06/30/2004
    6NDC:58933-011-903 in 1 BLISTER PACK10/04/2022
    65 in 1 CARTON
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00806/30/2004
    Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)
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!