Label: ANTI-DIARRHEAL- bismuth subsalicylate tablet

  • NDC Code(s): 66715-6841-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • Uses

    relieves:

    • indigestion
    • nausea
    • heartburn
    • diarrhea
    • upset stomach associated with these symptoms
  • 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

    • bloody or black stool
    • an ulcer
    • a bleeding problem

    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 of 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 immediately.

  • Directions

    • swallow caplet(s) with water, do not chew
    • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
    • do not take more than 8 doses (16 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 27 mg, salicylate 102 mg and sodium 2 mg
    • very low sodium
    • store at 59°-77°F (15°-25°C), in a dry place
  • Inactive ingredients

    calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate

  • Questions or comments?

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Product distributed by: Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW, Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton

    QUALITY
    ⋆ GUARANTEED ⋆

    Anti-
    Diarrheal

    Bismuth subsalicylate 262 mg

    Upset Stomach Reliever/
    Anti-diarrheal

    • Relieves the Symptoms
      of Diarrhea

    ACTUAL SIZE

    24
    Caplets

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6841
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6841-41 in 1 CARTON02/21/2019
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00802/21/2019
    Labeler - Lil' Drug Store Products, Inc. (093103646)