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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 11, 2019

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 finalpart33502/21/2019
    Labeler - Lil' Drug Store Products, Inc. (093103646)