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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 8, 2026

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  • 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

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL

    NDC 68788-4116-3

    Bismuth Subsalicylate

    262 mg

    UPSET STOMACH RELIEVER / ANTIDIARRHEAL

    30 CHEWABLE TABLETS

    *compare to Active Ingredients in Pepto-Bismol®

    Bismuth Subsalicylate Tablets 262mg
  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 262 MG 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-4116(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, UNSPECIFIED FORM (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:68788-4116-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2026
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00806/08/2026
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-4116)
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