Label: PEPTO BISMOL LIQUICAPS- bismuth subsalicylate capsule, liquid filled

  • NDC Code(s): 37000-535-12, 37000-535-24, 37000-535-48
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each LiquiCap)

    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

    • swallow with water, do not chew
    • adults and children 12 years and over:
    • 2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea
    • 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 16 LiquiCaps 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 LiquiCap contains:

    • salicylate 199 mg

    • low sodium

    • do not exceed 25°C

  • Inactive ingredients

    D&C Red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA
    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

    FAST & SOOTHING RELIEF

    Pepto
    Bismol®

    Bismuth Subsalicylate

    Upset Stomach Reliever/Antidiarrheal

    LIQUICAPS

    5 SYMPTOM RELIEF

    NAUSEA

    HEARTBURN

    INDIGESTION

    UPSET STOMACH

    DIARRHEA

    48 LIQUICAPS™

    535

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL  LIQUICAPS
    bismuth subsalicylate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-535
    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
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-535-121 in 1 CARTON03/01/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:37000-535-242 in 1 CARTON03/01/2019
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:37000-535-484 in 1 CARTON03/01/2019
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00803/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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