Label: BISMUTH SUBSALICYLATE 262 MG- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 69618-029-03
  • Packager: Reliable 1 Laboratories LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 15, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    Anti-diarrheal / Upset stomach reliever

  • Uses

    • controls diarrhea
    • relieves upset stomach due to overindulgence in food or drink
  • 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.

  • SPL UNCLASSIFIED SECTION

    Allergy alert: Contains salicylates. Do not take if you are:

    • allergic to salicylates (including aspirin)
    • taking other salicylate products
  • DO NOT USE

    Do not use

    • if you have bloody or black stool
    • if you have an ulcer or bleeding problem

    Drug Facts continued on back of label

  • ASK DOCTOR

    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

    When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • repeat dosage every 1/2 to 1 hour as needed
    • do not take more than 8 doses in 24 hours
    • use until diarrhea stops but not more than 2 days
    • adults and children 12 years and over: 2 tablets
    • children under 12 years: ask a doctor
  • Other information

    • each tablet contains: calcium 77 mg, salicylate 102 mg
    • store at 15°-30°C (59°-86°F)
    • protect from moisture
  • Inactive ingredients

    calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

  • Questions or comments?

    call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-029-03

    Bismuth Subsalicylate

    262 mg

    UPSET STOMACH RELIEVER / ANTIDIARRHEAL

    30 CHEWABLE TABLETS

    *compare to Active Ingredients in Pepto-Bismol®

    Bismuth

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 262 MG 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CHERRY (UNII: BUC5I9595W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code AP;045
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-029-0330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00811/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Registrant - Reliable 1 Laboratories LLC (079718111)